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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.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00087568
First received: July 12, 2004
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  Purpose

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: peginterferon alfa-2a [PEGASYS]
Drug: Ribavirin
 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:

U.S. FDA Resources

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 [ 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 58
Study Completion Date: August 2006
Arms Assigned Interventions
Experimental: 1
1
 Drug: peginterferon alfa-2a [PEGASYS]
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
Drug: Ribavirin
1000/1200mg po bid for 36 or 60 weeks

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087568

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

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00087568     History of Changes
Other Study ID Numbers: ML16965
Study First Received: July 12, 2004
Last Updated: May 13, 2009
Health Authority: United States: Food and Drug Administration

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
Peginterferon alfa-2b
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 16, 2013