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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02441283
Registration number
NCT02441283
Ethics application status
Date submitted
29/04/2015
Date registered
12/05/2015
Titles & IDs
Public title
A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
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Scientific title
A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
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Secondary ID [1]
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2015-000452-24
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Secondary ID [2]
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M13-576
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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:
Hepatitis C
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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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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - ABT-493
Treatment: Drugs - ABT-530
No intervention: HCV-infected Participants - Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study.
Treatment: Drugs: ABT-493
ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.
Treatment: Drugs: ABT-530
ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.
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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 Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
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Assessment method [1]
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Maintaining a sustained virologic response (SVR) is defined as having Hepatitis C virus ribonucleic acid (HCV RNA) value consistently below the lower limit of quantification (\< LLOQ) from the end of treatment in the previous study throughout Study M13-576 (this study).
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Timepoint [1]
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From the end of treatment in the previous study up to 3 years post-treatment
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Primary outcome [2]
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Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
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Assessment method [2]
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Relapse was defined as confirmed Hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (= LLOQ) between end of treatment and up to and including the last HCV RNA measurement collected in this study for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment, excluding reinfection. HCV reinfection was defined as confirmed HCV RNA = LLOQ after the end of treatment in a participant who had HCV RNA \< LLOQ at Final Treatment Visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences.
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Timepoint [2]
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From the end of treatment in the previous study up to 3 years post-treatment
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Primary outcome [3]
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Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure
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Assessment method [3]
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Plasma samples for HCV resistance testing were collected at study visits. The variants in nonstructural viral protein 3 (NS3) and nonstructural viral protein 5A (NS5A) at amino acid positions of interest were analyzed by next generation sequencing relative to baseline and prototypic reference sequences.
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Timepoint [3]
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From Day 1 to Month 12
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Secondary outcome [1]
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Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection
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Assessment method [1]
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Any events (i.e., diagnoses) related to liver disease progression and/or HCV infection considered to be clinically significant by the investigator that began or worsened after Day 1 were documented until the end of the study or initiation of re-treatment for HCV (if applicable). Significant events related to liver disease progression include the development of cirrhosis, events indicative of hepatic decompensation, (including: variceal bleeding, new ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome, hepatic hydrothorax or other evidence of hepatic decompensation considered to be significant by the investigator), change in the Child-Pugh category (e.g., change from Child-Pugh Class A to Child-Pugh Class B), the occurrence of hepatocellular carcinoma, liver transplantation and/or death.
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Timepoint [1]
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After Day 1 up to 3 years post-treatment
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Secondary outcome [2]
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Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time
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Assessment method [2]
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A plasma sample for IP-10 testing was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). IP-10 is used to assess liver fibrosis in participants with chronic liver disease.
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Timepoint [2]
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From Day 1 up to 3 years post-treatment
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Secondary outcome [3]
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Mean FibroTest Score Over Time
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Assessment method [3]
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A serum sample for FibroTest evaluation was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). FibroTest uses six biomarkers to generate a score that correlates to the degree of liver damage in participants. Scores range from 0 to 1, with higher scores indicating more severe liver fibrosis.
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Timepoint [3]
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From Day 1 up to 3 years post-treatment
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Secondary outcome [4]
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Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time
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Assessment method [4]
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A serum sample for aspartate transaminase evaluation and platelets were collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). The aspartate transaminase to platelet ratio index (APRI) is used to assess liver fibrosis in participants with chronic liver disease. Scores range from 0 to = 2.0, with scores \< 0.5 predictive of no liver fibrosis; scores \>1.5 significant fibrosis; and scores \> 2.0 indicative of cirrhosis.
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Timepoint [4]
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From Day 1 up to 3 years post-treatment
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Secondary outcome [5]
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Mean FibroScan Scores Over Time
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Assessment method [5]
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The FibroScan test is used to assess liver fibrosis in participants with chronic liver disease. This was not performed as a study procedure, but any available results from source documents were summarized. For participants with Hepatitis C infection, a Fibroscan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis.
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Timepoint [5]
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Up to 3 years post-treatment
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Eligibility
Key inclusion criteria
1. Participant is male or female 18 years of age or older
2. Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study
3. The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA) therapy from the previous clinical study and enrollment in Study M13-576 must be no longer than 2 years for subjects who have not been retreated. Participants who have been treated with a commercially available anti-HCV treatment may be enrolled greater than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical study.
4. Participant must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures.
5. Participant completed the post-treatment period of an eligible prior study.
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Minimum age
18
Years
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Maximum age
80
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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
1. The investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study).
2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.
3. Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530.
4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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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
Single group
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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
22/06/2015
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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
15/10/2019
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Sample size
Target
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Accrual to date
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Final
384
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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St. Vincent's Hospital, Darlinghurst /ID# 155395 - Darlinghurst
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Recruitment hospital [2]
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St. Vincents Hospital /ID# 155394 - East Lismore
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Recruitment hospital [3]
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Westmead Hospital /ID# 155392 - Westmead
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Recruitment hospital [4]
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Royal Brisbane and Women's Hospital /ID# 155396 - Herston
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Recruitment hospital [5]
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Royal Adelaide Hospital /ID# 155391 - Adelaide
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Recruitment hospital [6]
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Royal Melbourne Hospital /ID# 155393 - Parkville
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2480 - East Lismore
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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United States of America
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Florida
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United States of America
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Louisiana
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United States of America
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Michigan
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United States of America
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State/province [6]
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New York
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United States of America
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State/province [7]
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North Carolina
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Belgium
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Bruxelles-Capitale
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Belgium
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Brussels
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Ontario
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Germany
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Hessen
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Germany
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Dusseldorf
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Germany
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Kiel
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New Zealand
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Auckland
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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United Kingdom
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London, City Of
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United Kingdom
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London
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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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 was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.
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Trial website
https://clinicaltrials.gov/study/NCT02441283
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Trial related presentations / publications
Poordad F, Felizarta F, Yao BB, Overcash JS, Hassanein T, Agarwal K, Gane E, Shaw D, Waters M, Krishnan P, Topp A, Burroughs M, Nevens F. Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study. Liver Int. 2022 Jun;42(6):1278-1286. doi: 10.1111/liv.15211. Epub 2022 Mar 14.
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Public notes
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Contacts
Principal investigator
Name
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AbbVie Inc.
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Address
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AbbVie
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Fax
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Contact person for public queries
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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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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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: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/83/NCT02441283/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/83/NCT02441283/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02441283