- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00192647
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
June 23, 2016 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
896
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1640
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Buenos Aires, Argentina, C1282AFE
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La Plata, Argentina, B1902AVF
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Rosario, Argentina, 2000
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Adelaide, Australia, 5000
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Adelaide, Australia, 5042
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Bankstown, Australia, 2200
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Box Hill, Australia, 3128
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Brisbane, Australia, 4029
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Cottontree, Australia, 4558
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Darlinghurst, Australia, 2010
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Douglas, Australia
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Fitzroy, Australia, 3065
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Fremantle, Australia, 6160
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Geelong, Australia, 3220
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Greenslopes, Australia, 4120
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Kingswood, Australia
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Lismore, Australia, 2480
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Liverpool, Australia, 1871
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Liverpool, Australia, 2170
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Melbourne, Australia, 3181
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Melbourne, Australia, 3084
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Melbourne, Australia, 3011
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Melbourne, Australia, 3186
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Miranda, Australia, 2228
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Nedlands, Australia, 6009
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New Lambton Heights, Australia, 2310
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Parkville, Australia, 3052
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Perth, Australia, 6001
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Sydney, Australia, 2050
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Sydney, Australia, 2145
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Sydney, Australia, 2139
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Sydney, Australia, 2010
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Victoria, Australia, 3199
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Woden, Australia, 2606
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Wollongong, Australia, 2500
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Woolloongabba, Australia, 4102
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
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Edmonton, Alberta, Canada, T5H 4B9
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
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Ontario
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Mississauga, Ontario, Canada, L5M 2V8
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Guadalajara, Mexico, 44650
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Guadalajara, Mexico, 44280
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Monterrey, Mexico, 64460
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Auckland, New Zealand, 100
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Hamilton, New Zealand
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Riccarton, Christchurch, New Zealand, 8011
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50202
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Other Names:
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Other Names:
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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.
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PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Other Names:
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
Time Frame: Week 72
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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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Week 72
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Time Frame: Weeks 48
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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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Weeks 48
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Percentage of Participants With Virological Responses Over Time
Time Frame: Weeks 4, 8, 12, and 24
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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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Weeks 4, 8, 12, and 24
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Percentage of Participants With Relapse of End-of-treatment Virological Response
Time Frame: Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
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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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Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
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Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
Time Frame: Weeks 4, 12, and 72
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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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Weeks 4, 12, and 72
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Change From Baseline in Log10 HCV RNA Values
Time Frame: Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
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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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Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
August 4, 2016
Last Update Submitted That Met QC Criteria
June 23, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Ribavirin
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- ML17908
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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