A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
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
1 other identifier
interventional
896
6 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2004
Longer than P75 for phase_4
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
June 14, 2016
CompletedAugust 4, 2016
June 1, 2016
4.6 years
September 13, 2005
May 6, 2016
June 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
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.
Week 72
Secondary Outcomes (5)
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Weeks 48
Percentage of Participants With Virological Responses Over Time
Weeks 4, 8, 12, and 24
Percentage of Participants With Relapse of End-of-treatment Virological Response
Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
Weeks 4, 12, and 72
Change From Baseline in Log10 HCV RNA Values
Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
Study Arms (2)
PEG-IFN alfa-2a+Ribavirin - Induction Treatment
EXPERIMENTALParticipants 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.
PEG-IFN alfa-2a+Ribavirin - Standard Treatment
EXPERIMENTALParticipants 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.
Interventions
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Buenos Aires, 1640, Argentina
Unknown Facility
Buenos Aires, C1282AFE, Argentina
Unknown Facility
La Plata, B1902AVF, Argentina
Unknown Facility
Rosario, 2000, Argentina
Unknown Facility
Adelaide, 5000, Australia
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Adelaide, 5042, Australia
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Bankstown, 2200, Australia
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Box Hill, 3128, Australia
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Brisbane, 4029, Australia
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Cottontree, 4558, Australia
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Darlinghurst, 2010, Australia
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Douglas, Australia
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Fitzroy, 3065, Australia
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Fremantle, 6160, Australia
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Geelong, 3220, Australia
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Greenslopes, 4120, Australia
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Kingswood, Australia
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Lismore, 2480, Australia
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Liverpool, 1871, Australia
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Liverpool, 2170, Australia
Unknown Facility
Melbourne, 3011, Australia
Unknown Facility
Melbourne, 3084, Australia
Unknown Facility
Melbourne, 3181, Australia
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Melbourne, 3186, Australia
Unknown Facility
Miranda, 2228, Australia
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Nedlands, 6009, Australia
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New Lambton Heights, 2310, Australia
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Parkville, 3052, Australia
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Perth, 6001, Australia
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Sydney, 2010, Australia
Unknown Facility
Sydney, 2050, Australia
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Sydney, 2139, Australia
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Sydney, 2145, Australia
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Victoria, 3199, Australia
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Woden, 2606, Australia
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Wollongong, 2500, Australia
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Woolloongabba, 4102, Australia
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Calgary, Alberta, T2N 4N1, Canada
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Edmonton, Alberta, T5H 4B9, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Mississauga, Ontario, L5M 2V8, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Guadalajara, 44280, Mexico
Unknown Facility
Guadalajara, 44650, Mexico
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Monterrey, 64460, Mexico
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Auckland, 100, New Zealand
Unknown Facility
Hamilton, New Zealand
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Riccarton, Christchurch, 8011, New Zealand
Unknown Facility
Bangkok, 10400, Thailand
Unknown Facility
Bangkok, 10700, Thailand
Unknown Facility
Chiang Mai, 50202, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
August 1, 2004
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 4, 2016
Results First Posted
June 14, 2016
Record last verified: 2016-06