A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: July 12, 2004
Last updated: October 1, 2015
Last verified: October 2015
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Ribavirin
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Safety and Tolerability of PEGASYS Plus Ribavirin in Patients With Chronic Hepatitis C Viral Infection Who Could Not Tolerate or Were Unresponsive to PEG-Intron Plus Ribavirin

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients able to complete prescribed length of Pegasys plus ribavirin therapy\n [ Time Frame: 36 and 60 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sum score of Beck Depression Inventory and Fatigue Severity Score, proportion of patients with each flu-like symptom, >=2 log drop or undetectable HCV-RNA, or normal ALT levels, adverse events, laboratory values\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: December 2002
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Ribavirin
1000/1200mg po bid for 36 or 60 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients at least 18 years of age
  • CHC infection, genotype 1
  • unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
  • use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

  • women who are pregnant or breast-feeding
  • medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
  • patients with decompensated cirrhosis
  • patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00087568

  Show 25 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00087568     History of Changes
Other Study ID Numbers: ML16965 
Study First Received: July 12, 2004
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 25, 2016