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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02010255
Registration number
NCT02010255
Ethics application status
Date submitted
9/12/2013
Date registered
12/12/2013
Titles & IDs
Public title
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
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Scientific title
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant
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Secondary ID [1]
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2013-002802-30
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Secondary ID [2]
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GS-US-337-0124
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic HCV Infection
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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0
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Liver
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LDV/SOF
Treatment: Drugs - RBV
Experimental: Cohort A, Group 1 (12 wk): CPT Class B (7-9) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Experimental: Cohort A, Group 1 (24 wk): CPT Class B (7-9) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Experimental: Cohort A, Group 2 (12 wk): CPT Class C (10-12) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Experimental: Cohort A, Group 2 (24 wk): CPT Class C (10-12) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Experimental: Cohort B, Group 3 (12 wk): F0-F3 Fibrosis - LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, = 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
Experimental: Cohort B, Group 3 (24 wk): F0-F3 Fibrosis - LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, = 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Experimental: Cohort B, Group 4 (12 wk): CPT Class A (5-6) - LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, = 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
Experimental: Cohort B, Group 4 (24 wk): CPT Class A (5-6) - LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, = 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
Experimental: Cohort B, Group 5 (12 wk): CPT Class B (7-9) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Experimental: Cohort B, Group 5 (24 wk): CPT Class B (7-9) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Experimental: Cohort B, Group 6 (12 wk): CPT Class C (10-12) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Experimental: Cohort B, Group 6 (24 wk): CPT Class C (10-12) - LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, = 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Experimental: Cohort B, Group 7 (12 wk): FCH - LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, = 75 kg = 1200 mg) for 12 weeks in participants with FCH
Experimental: Cohort B, Group 7 (24 wk): FCH - LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, = 75 kg = 1200 mg) for 24 weeks in participants with FCH
Treatment: Drugs: LDV/SOF
LDV/SOF FDC tablet administered orally once daily
Treatment: Drugs: RBV
RBV tablets administered orally in a divided daily dose
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
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Assessment method [1]
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SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
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Timepoint [1]
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Posttreatment Week 12
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Primary outcome [2]
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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
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Assessment method [2]
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Timepoint [2]
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Up to 24 weeks
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Secondary outcome [1]
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Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
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Assessment method [1]
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SVR2 was defined as HCV RNA \< LLOQ at 2 weeks after stopping study treatment.
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Timepoint [1]
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Posttreatment Week 2
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Secondary outcome [2]
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Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
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Assessment method [2]
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SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
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Timepoint [2]
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Posttreatment Week 4
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Secondary outcome [3]
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Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
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Assessment method [3]
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SVR8 was defined as HCV RNA \< LLOQ at 8 weeks after stopping study treatment.
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Timepoint [3]
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Posttreatment Week 8
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Secondary outcome [4]
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Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
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Assessment method [4]
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SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
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Timepoint [4]
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Posttreatment Week 24
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Secondary outcome [5]
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Percentage of Participants With Virologic Failure
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Assessment method [5]
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Virologic failure was defined as:
* On-treatment virologic failure:
* Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA \< LLOQ on 2 consecutive measurements while on treatment), or
* Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)
* Virologic relapse:
* Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
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Timepoint [5]
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Up to Posttreatment Week 24
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Secondary outcome [6]
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Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
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Assessment method [6]
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pTVR was defined as HCV RNA \< LLOQ at Week 12 after transplant.
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Timepoint [6]
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Posttreatment Week 12
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Secondary outcome [7]
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Percentage of Participants With HCV RNA < LLOQ at Week 1
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Assessment method [7]
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Timepoint [7]
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Week 1
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Secondary outcome [8]
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Percentage of Participants With HCV RNA < LLOQ at Week 2
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Assessment method [8]
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Timepoint [8]
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Week 2
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Secondary outcome [9]
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Percentage of Participants With HCV RNA < LLOQ at Week 4
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Assessment method [9]
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Timepoint [9]
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Week 4
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Secondary outcome [10]
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Percentage of Participants With HCV RNA < LLOQ at Week 6
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Assessment method [10]
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Timepoint [10]
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Week 6
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Secondary outcome [11]
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Percentage of Participants With HCV RNA < LLOQ at Week 8
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Assessment method [11]
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Timepoint [11]
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Week 8
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Secondary outcome [12]
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Percentage of Participants With HCV RNA < LLOQ at Week 12
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Assessment method [12]
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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Percentage of Participants With HCV RNA < LLOQ at Week 16
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Assessment method [13]
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Timepoint [13]
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Week 16
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Secondary outcome [14]
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Percentage of Participants With HCV RNA < LLOQ at Week 20
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Assessment method [14]
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Timepoint [14]
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Week 20
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Secondary outcome [15]
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Percentage of Participants With HCV RNA < LLOQ at Week 24
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Assessment method [15]
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Timepoint [15]
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Week 24
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Secondary outcome [16]
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HCV RNA Levels and Change From Baseline at Week 1
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Assessment method [16]
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Timepoint [16]
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Baseline; Week 1
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Secondary outcome [17]
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HCV RNA Levels and Change From Baseline at Week 2
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Assessment method [17]
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Timepoint [17]
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Baseline; Week 2
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Secondary outcome [18]
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HCV RNA Levels and Change From Baseline at Week 4
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Assessment method [18]
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Timepoint [18]
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Baseline; Week 4
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Secondary outcome [19]
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HCV RNA Levels and Change From Baseline at Week 6
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Assessment method [19]
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Timepoint [19]
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Baseline; Week 6
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Secondary outcome [20]
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HCV RNA Levels and Change From Baseline at Week 8
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Assessment method [20]
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Timepoint [20]
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Baseline; Week 8
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Secondary outcome [21]
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HCV RNA Levels and Change From Baseline at Week 12
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Assessment method [21]
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Timepoint [21]
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Baseline; Week 12
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Secondary outcome [22]
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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
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Assessment method [22]
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Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
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Timepoint [22]
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Baseline to Posttreatment Week 4
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Secondary outcome [23]
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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
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Assessment method [23]
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CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.
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Timepoint [23]
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Baseline to Posttreatment Week 4
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Eligibility
Key inclusion criteria
* Able to provide written informed consent
* Chronic genotype 1 and/or 4 HCV infection
* Normal ECG
* Negative serum pregnancy test for female subjects
* Male subjects and female subjects of childbearing potential must agree to use contraception
* Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Serious or active medical or psychiatric illness
* HIV or hepatitis B viral (HBV) infection
* Stomach disorder that could interfere with the absorption of the study drug
* Treated with an anti-HCV medication in the last 30 days
* Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
* Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
* History of clinically significant medical condition associated with other chronic liver disease
* Active spontaneous bacterial peritonitis at screening
* Females who are breastfeeding
* Infection requiring systemic antibiotics
* Participated in a clinical study with an investigational drug or biologic within the last 30 days
* Active or history (last 6 months) of drug or alcohol abuse
* History of organ transplant other than liver, kidney, or corneal.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2015
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Sample size
Target
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Accrual to date
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Final
334
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital, University of Sydney - Camperdown
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Recruitment hospital [2]
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Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre - Heidelberg
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Innsbruck
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Country [2]
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Austria
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State/province [2]
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Wien
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Country [3]
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Belgium
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State/province [3]
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Brussels
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Country [4]
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Belgium
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State/province [4]
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Gent
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Country [5]
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Canada
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State/province [5]
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Alberta
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Country [6]
0
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Canada
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State/province [6]
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British Columbia
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Country [7]
0
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Canada
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State/province [7]
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Ontario
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Country [8]
0
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Canada
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State/province [8]
0
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Quebec
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Country [9]
0
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France
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State/province [9]
0
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Clichy Cedex
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Country [10]
0
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France
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State/province [10]
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Créteil
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Country [11]
0
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France
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State/province [11]
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Montpellier
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Country [12]
0
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France
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State/province [12]
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Villejuif Cedex
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Country [13]
0
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Germany
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State/province [13]
0
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Aachen
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Country [14]
0
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Germany
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State/province [14]
0
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Essen
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Country [15]
0
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Germany
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State/province [15]
0
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Frankfurt
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Country [16]
0
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Germany
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State/province [16]
0
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Hannover
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Country [17]
0
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Italy
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State/province [17]
0
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Milano
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Country [18]
0
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Italy
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State/province [18]
0
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Torino
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Country [19]
0
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Netherlands
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State/province [19]
0
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Leiden
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Country [20]
0
0
Netherlands
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State/province [20]
0
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Rotterdam
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Country [21]
0
0
New Zealand
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State/province [21]
0
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Auckland
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Country [22]
0
0
Spain
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State/province [22]
0
0
Barcelona
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Country [23]
0
0
Spain
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State/province [23]
0
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Madrid
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Country [24]
0
0
Spain
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State/province [24]
0
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Valencia
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Country [25]
0
0
Switzerland
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State/province [25]
0
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Bern
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Country [26]
0
0
Switzerland
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State/province [26]
0
0
Zurich
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Country [27]
0
0
United Kingdom
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State/province [27]
0
0
Birmingham
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Country [28]
0
0
United Kingdom
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State/province [28]
0
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Edinburgh
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Country [29]
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0
United Kingdom
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State/province [29]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. * Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; * Cohort B: post-liver transplant, with or without cirrhosis; * Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) * Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.
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Trial website
https://clinicaltrials.gov/study/NCT02010255
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Trial related presentations / publications
Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Mullhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. Epub 2016 Feb 18. Erratum In: Lancet Infect Dis. 2016 Jun;16(6):636. doi: 10.1016/S1473-3099(16)30085-8.
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Public notes
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Contacts
Principal investigator
Name
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Shampa De-Oertel, PhD
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Address
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Gilead Sciences
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Country
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02010255