A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144469
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : February 2, 2009
Information provided by:
Chugai Pharmaceutical

Brief Summary:

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.

Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: peginterferon alfa-2a Drug: rivavirin Phase 3

Detailed Description:

Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.

All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C
Study Start Date : May 2002
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).

Secondary Outcome Measures :
  1. Biochemical response (normalization of serum alanine aminotransferase activity),
  2. Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
  • elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
  • liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

  • Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
  • leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
  • thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
  • anemia (less than 12 g hemoglobin per deciliter )
  • hepatitis B co-infection
  • decompensated liver disease
  • organ transplant
  • creatinine clearance less than 50 milliliters per minute
  • poorly controlled psychiatric disease
  • poorly controlled diabetes
  • malignant neoplastic disease
  • severe cardiac or chronic pulmonary disease
  • immunologically mediated disease
  • retinopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144469

Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Hirokazu Furuta Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical Identifier: NCT00144469     History of Changes
Other Study ID Numbers: JV15725
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009

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