A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01258101
First received: November 29, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This randomized, parallel arm study will evaluate the efficacy and safety of Peg asys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomiz ed to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for e ither 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-wee k follow-up.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Multicenter Study to Compare Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virologic response rate (Hepatitis C Virus-RNA determined by AMPLICOR HCV test) [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
  • Hepatitis C Virus-RNA determined by AMPLICOR HCV test) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virologic response rates (Hepatitis C Virus-RNA determined by AMPLICOR HCV test) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Virologic response rates (Hepatitis C Virus-RNA determined by AMPLICOR HCV test) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin levels at end of treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin levels at end of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Health Survey (Short Form 36) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 393
Study Start Date: May 2003
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
Drug: ribavirin
800 mg orally daily
Experimental: B Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
Drug: ribavirin
400 mg orally daily
Experimental: C Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 16 weeks
Drug: ribavirin
800 mg orally daily
Experimental: D Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 16 weeks
Drug: ribavirin
400 mg orally daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 18-65 years of age
  • Chronic hepatitis C, genotype 2 or 3
  • Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
  • Abdominal sonography within 3 months prior to study start

Exclusion Criteria:

  • Previous interferon and/or pegylated interferon and ribavirin therapy
  • Liver cirrhosis, class B or C (Child-Pugh)
  • Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug
  • History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
  • Decompensated liver disease
  • Positive for HIV
  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: NCT01258101

Locations
Austria
Gratwein, Austria, 8112
Graz, Austria, 8036
Innsbruck, Austria, 6020
Krems, Austria, 3500
Linz, Austria, 4010
Linz, Austria, 4020
Oberndorf, Austria, 5110
Oberpullendorf, Austria, 7350
Ried-innkreis, Austria, 4910
Salzburg, Austria, 5020
Villach, Austria, 9500
Vöcklabruck, Austria, 4840
Wels, Austria, 4600
Wien, Austria, 1160
Wien, Austria, 1100
Wien, Austria, 1130
Wien, Austria, 1090
Wien, Austria, 1140
Wien, Austria, 1220
Wien, Austria, 1030
Wiener Neustadt, Austria, 2700
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01258101     History of Changes
Other Study ID Numbers: ML17087
Study First Received: November 29, 2010
Last Updated: August 4, 2014
Health Authority: Austria: Federal Ministry for Health and Women

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014