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A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00304551
First received: March 5, 2006
Last updated: June 1, 2010
Last verified: June 2010
History of Changes
  Purpose

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.

Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.


Condition Intervention Phase
Liver Cirrhosis
Chronic Hepatitis C
 Drug: peginterferon alfa-2a 180μg
Drug: peginterferon alfa-2a 90μg
Drug: ribavirin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC

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 hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL]) [ Time Frame: week 24 from the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical response (normalization of serum alanine aminotransferase activity) [ Time Frame: at the end of treatment and week 24 form the end of treatment ] [ Designated as safety issue: No ]
  • Virological response (HCV-RNA < 50 IU per milliliter) [ Time Frame: at the end of treatment and week 24 form the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2006
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a 180μg
180μg（s.c.）/week for 48 weeks
Drug: ribavirin
600, 800, or 1,000 mg X 2(p.o.)/day
Experimental: 2 Drug: peginterferon alfa-2a 90μg
90μg(s.c.)/week for 48 weeks
Drug: ribavirin
600, 800, or 1,000 mg X 2(p.o.)/day
No Intervention: 3

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.

Exclusion Criteria:

  • Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
  • Thrombocytopenia (fewer than 75,000 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: NCT00304551

Locations
Japan
Chugoku
Chugoku, Japan
Hokkaido Region
Hokkaido, Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Kyusyu Region
Kyusyu, Japan
Shikoku Region
Shikoku, Japan
Tohoku Region
Tohoku, Japan
Tokai Region
Tokai, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Takehiko Aoshima Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00304551     History of Changes
Other Study ID Numbers: JV19595
Study First Received: March 5, 2006
Last Updated: June 1, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Chugai Pharmaceutical:
CHC with compensated LC

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Fibrosis
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Pathologic Processes
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 16, 2013