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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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ClinicalTrials.gov Identifier: NCT01296971
Recruitment Status : Withdrawn (study was not started due to an administrative reason on the part of the local Health Authority)
First Posted : February 16, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin [Copegus] Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
genotype 1, treatment-naive
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
Drug: ribavirin [Copegus]
1'000/1'200 mg daily orally, 24 - 72 weeks
Experimental: B
genotype 2 and 3, treatment-naive
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
Drug: ribavirin [Copegus]
800 mg daily orally, 16 - 48 weeks
Experimental: C
all genotypes, non-responders or relapses
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
Drug: ribavirin [Copegus]
1'000/1'200 mg daily orally, 24 - 72 weeks



Primary Outcome Measures :
  1. Safety of individualized Copegus treatment in combination with Pegasys: Adverse events [ Time Frame: up to 96 weeks ]
  2. Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA) [ Time Frame: up to 96 weeks ]

Secondary Outcome Measures :
  1. Virological response/sustained virological response (serum HCV RNA levels) [ Time Frame: 24 weeks after treatment completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296971


Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01296971     History of Changes
Other Study ID Numbers: ML25246
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs