- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01296971
A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)
November 1, 2016 updated by: Hoffmann-La Roche
Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)
This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks.
For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks.
Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks.
Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients.
Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Chronic hepatitis C
- Measurable serum HVC RNA levels
- Compensated liver disease (Child-Pugh class A)
- Treatment-naive for standard or pegylated interferons, or non-responder or relapsing
Exclusion Criteria:
- Concomitant hepatitis A or B
- History of chronic liver disease not caused by hepatitis C virus
- Hepatocellular carcinoma
- History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
- Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
- Pregnant or lactating women, or men whose partners are pregnant
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 |
---|---|
Experimental: A
genotype 1, treatment-naive
|
180 mcg sc weekly
1'000/1'200 mg daily orally, 24 - 72 weeks
800 mg daily orally, 16 - 48 weeks
|
Experimental: B
genotype 2 and 3, treatment-naive
|
180 mcg sc weekly
1'000/1'200 mg daily orally, 24 - 72 weeks
800 mg daily orally, 16 - 48 weeks
|
Experimental: C
all genotypes, non-responders or relapses
|
180 mcg sc weekly
1'000/1'200 mg daily orally, 24 - 72 weeks
800 mg daily orally, 16 - 48 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
Time Frame: up to 96 weeks
|
up to 96 weeks
|
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
Time Frame: up to 96 weeks
|
up to 96 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Virological response/sustained virological response (serum HCV RNA levels)
Time Frame: 24 weeks after treatment completion
|
24 weeks after treatment completion
|
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
December 1, 2009
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
December 21, 2010
First Submitted That Met QC Criteria
February 15, 2011
First Posted (Estimate)
February 16, 2011
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 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
- Ribavirin
- Peginterferon alfa-2a
Other Study ID Numbers
- ML25246
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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