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

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144469

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 III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C

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

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	JV15725
Study First Received:	September 2, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00144469
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009