A Study of Induction Dosing With Peginterferon Alfa-2a (40KD) and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00192647
First received: September 13, 2005
Last updated: March 1, 2016
Last verified: March 2016
  Purpose
This study will evaluate the addition of a higher-dose induction treatment period with peginterferon alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with Pegasys and ribavirin, compared to standard-dose treatment without induction dosing, in treatment-naive participants with CHC, genotype 1. The anticipated time on study treatment is 48 weeks, and the target sample size is 500 or more individuals.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Phase 4

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: A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of participants with sustained virologic response [ Time Frame: 24 weeks following completion of the 48-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) [ Time Frame: Weeks 4, 8, 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Percentage of participants with at least a 2-log drop in HCV RNA or unquantifiable/undetectable HCV RNA [ Time Frame: Weeks 4, 8, 12, and 24 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Up to approximately 12 months ] [ Designated as safety issue: No ]

Enrollment: 896
Study Start Date: September 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction Treatment
Participants will receive 12 weeks of induction therapy with peginterferon alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, plus ribavirin, 1000 or 1200 milligrams (mg) orally (PO) daily in divided doses. Thereafter, the dose of peginterferon alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
Drug: Peginterferon alfa-2a
For induction, participants will receive 360 mcg SC once weekly for 12 weeks. The standard regimen will include 180 mcg SC once weekly for 36 or 48 weeks, depending upon treatment assignment.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive 1000 or 1200 mg PO daily in divided doses, with the dose determined using body weight, for 48 weeks.
Experimental: Standard Treatment
Participants will receive 48 weeks of standard therapy with peginterferon alfa-2a (Pegasys), 180 mcg SC once weekly, plus ribavirin, 1000 or 1200 mg PO daily in divided doses.
Drug: Peginterferon alfa-2a
For induction, participants will receive 360 mcg SC once weekly for 12 weeks. The standard regimen will include 180 mcg SC once weekly for 36 or 48 weeks, depending upon treatment assignment.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive 1000 or 1200 mg PO daily in divided doses, with the dose determined using body weight, for 48 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 to 75 years of age
  • Diagnosis of chronic CHC, genotype 1
  • Chronic liver disease consistent with CHC infection per Australian Section 100 criteria
  • Compensated liver disease
  • Naive to interferon-based therapy for CHC infection

Exclusion Criteria:

  • Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
  • Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
  • Chronic liver disease other than CHC infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192647

  Show 51 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00192647     History of Changes
Other Study ID Numbers: ML17908 
Study First Received: September 13, 2005
Last Updated: March 1, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hepatitis
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
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016