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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144469
First received: September 2, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Chronic Hepatitis C
 Drug: peginterferon alfa-2a
Drug: rivavirin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

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

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

Enrollment: 300
Study Start Date: May 2002
Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144469

Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Hirokazu Furuta Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144469     History of Changes
Other Study ID Numbers: JV15725
Study First Received: September 2, 2005
Last Updated: January 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
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 23, 2013