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

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00304551

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 III

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

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

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
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: Experimental	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
3: No Intervention

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
Hokkaido Region
Hokkaido, Japan
Tohoku Region
Tohoku, Japan
Kanto Region
Kanto, Japan
Tokai Region
Tokai, Japan
Kyusyu Region
Kyusyu, Japan
Chugoku
Chugoku, Japan
Shikoku Region
Shikoku, Japan
Kinki Region
Kinki, Japan

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Takehiko Aoshima

Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	JV19595
Study First Received:	March 5, 2006
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00304551
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Chugai Pharmaceutical:

CHC with compensated LC

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Fibrosis
Interferons
Ribavirin
Hepatitis, Viral, Human
Liver Cirrhosis

Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009