Back to resultsA Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)
Primary Purpose
Hepatitis C, Chronic
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
ribavirin [Copegus]
ribavirin [Copegus]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A
B
C
Arm Description
genotype 1, treatment-naive
genotype 2 and 3, treatment-naive
all genotypes, non-responders or relapses
Outcomes
Primary Outcome Measures
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
Secondary Outcome Measures
Virological response/sustained virological response (serum HCV RNA levels)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01296971
Brief Title
A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
study was not started due to an administrative reason on the part of the local Health Authority
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
genotype 1, treatment-naive
Arm Title
B
Arm Type
Experimental
Arm Description
genotype 2 and 3, treatment-naive
Arm Title
C
Arm Type
Experimental
Arm Description
all genotypes, non-responders or relapses
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly
Intervention Type
Drug
Intervention Name(s)
ribavirin [Copegus]
Intervention Description
1'000/1'200 mg daily orally, 24 - 72 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin [Copegus]
Intervention Description
800 mg daily orally, 16 - 48 weeks
Primary Outcome Measure Information:
Title
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
Time Frame
up to 96 weeks
Title
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
Time Frame
up to 96 weeks
Secondary Outcome Measure Information:
Title
Virological response/sustained virological response (serum HCV RNA levels)
Time Frame
24 weeks after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)
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