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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00192647
Registration number
NCT00192647
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
4/08/2016
Titles & IDs
Public title
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
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Scientific title
A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1
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Secondary ID [1]
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ML17908
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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, Chronic
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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
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Description of intervention(s) / exposure
Treatment: Drugs - PEG-IFN alfa-2a
Treatment: Drugs - Ribavirin
Experimental: PEG-IFN alfa-2a+Ribavirin - Induction Treatment - Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
Experimental: PEG-IFN alfa-2a+Ribavirin - Standard Treatment - Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
Treatment: Drugs: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Treatment: Drugs: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
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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 Virological Response According to Scheduled Treatment Period
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Assessment method [1]
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Sustained virological response was calculated as the percentage of participants with undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.
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Timepoint [1]
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Week 72
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Secondary outcome [1]
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Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
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Assessment method [1]
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Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (\<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.
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Timepoint [1]
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Weeks 48
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Secondary outcome [2]
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Percentage of Participants With Virological Responses Over Time
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Assessment method [2]
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Virological response was defined as undetectable HCV RNA (\<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.
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Timepoint [2]
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Weeks 4, 8, 12, and 24
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Secondary outcome [3]
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Percentage of Participants With Relapse of End-of-treatment Virological Response
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Assessment method [3]
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Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (\<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.
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Timepoint [3]
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Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
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Secondary outcome [4]
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Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
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Assessment method [4]
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The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.
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Timepoint [4]
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Weeks 4, 12, and 72
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Secondary outcome [5]
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Change From Baseline in Log10 HCV RNA Values
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Assessment method [5]
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The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.
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Timepoint [5]
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Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
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Eligibility
Key inclusion criteria
* Diagnosis of chronic CHC, genotype 1
* Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
* Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
* Compensated liver disease
* Naive to interferon-based therapy for CHC infection
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Minimum age
18
Years
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Maximum age
75
Years
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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
* Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
* Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
* Chronic liver disease other than CHC infection
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 4
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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
1/08/2004
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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
1/03/2009
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Sample size
Target
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Accrual to date
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Final
896
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Bankstown
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Recruitment hospital [3]
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- Box Hill
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Recruitment hospital [4]
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- Brisbane
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Recruitment hospital [5]
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- Cottontree
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Recruitment hospital [6]
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- Darlinghurst
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Recruitment hospital [7]
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- Douglas
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Recruitment hospital [8]
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- Fitzroy
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Recruitment hospital [9]
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- Fremantle
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Recruitment hospital [10]
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- Geelong
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Recruitment hospital [11]
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- Greenslopes
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Recruitment hospital [12]
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- Kingswood
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Recruitment hospital [13]
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- Lismore
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Recruitment hospital [14]
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- Liverpool
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Recruitment hospital [15]
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- Melbourne
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Recruitment hospital [16]
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- Miranda
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Recruitment hospital [17]
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- Nedlands
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Recruitment hospital [18]
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- New Lambton Heights
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Recruitment hospital [19]
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- Parkville
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Recruitment hospital [20]
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- Perth
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Recruitment hospital [21]
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- Sydney
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Recruitment hospital [22]
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- Victoria
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Recruitment hospital [23]
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- Woden
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Recruitment hospital [24]
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- Wollongong
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Recruitment hospital [25]
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- Woolloongabba
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5042 - Adelaide
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Recruitment postcode(s) [3]
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2200 - Bankstown
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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4029 - Brisbane
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Recruitment postcode(s) [6]
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4558 - Cottontree
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Recruitment postcode(s) [7]
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2010 - Darlinghurst
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Recruitment postcode(s) [8]
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- Douglas
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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Recruitment postcode(s) [10]
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6160 - Fremantle
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Recruitment postcode(s) [11]
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3220 - Geelong
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Recruitment postcode(s) [12]
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4120 - Greenslopes
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Recruitment postcode(s) [13]
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- Kingswood
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Recruitment postcode(s) [14]
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2480 - Lismore
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Recruitment postcode(s) [15]
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1871 - Liverpool
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Recruitment postcode(s) [16]
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2170 - Liverpool
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Recruitment postcode(s) [17]
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3011 - Melbourne
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Recruitment postcode(s) [18]
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3084 - Melbourne
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Recruitment postcode(s) [19]
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3181 - Melbourne
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Recruitment postcode(s) [20]
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3186 - Melbourne
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Recruitment postcode(s) [21]
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2228 - Miranda
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Recruitment postcode(s) [22]
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6009 - Nedlands
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Recruitment postcode(s) [23]
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2310 - New Lambton Heights
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Recruitment postcode(s) [24]
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3052 - Parkville
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Recruitment postcode(s) [25]
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6001 - Perth
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Recruitment postcode(s) [26]
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2010 - Sydney
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Recruitment postcode(s) [27]
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2050 - Sydney
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Recruitment postcode(s) [28]
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2139 - Sydney
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Recruitment postcode(s) [29]
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2145 - Sydney
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Recruitment postcode(s) [30]
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3199 - Victoria
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Recruitment postcode(s) [31]
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2606 - Woden
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Recruitment postcode(s) [32]
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2500 - Wollongong
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Recruitment postcode(s) [33]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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State/province [2]
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La Plata
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Argentina
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Rosario
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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State/province [6]
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Ontario
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Country [7]
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Canada
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State/province [7]
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Quebec
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Country [8]
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Mexico
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State/province [8]
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Guadalajara
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Mexico
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State/province [9]
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Monterrey
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New Zealand
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State/province [10]
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Auckland
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Country [11]
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New Zealand
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State/province [11]
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Hamilton
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Country [12]
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New Zealand
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State/province [12]
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Riccarton, Christchurch
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Country [13]
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Thailand
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State/province [13]
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Bangkok
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Country [14]
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Thailand
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State/province [14]
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Chiang Mai
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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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 the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.
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Trial website
https://clinicaltrials.gov/study/NCT00192647
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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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 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
No information has been provided regarding IPD availability
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/NCT00192647
Download to PDF