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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)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01296971
First received: December 21, 2010
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Hepatitis C, Chronic
 Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety of individualized Copegus treatment in combination with Pegasys: Adverse events [ Time Frame: up to 96 weeks ] [ Designated as safety issue: No ]
  • Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA) [ Time Frame: up to 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response/sustained virological response (serum HCV RNA levels) [ Time Frame: 24 weeks after treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296971

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

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01296971     History of Changes
Other Study ID Numbers: ML25246
Study First Received: December 21, 2010
Last Updated: July 22, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013