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

Tracking Information

First Received Date ^ICMJE

March 5, 2006

Last Updated Date

June 1, 2010

Start Date ^ICMJE

June 2006

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00304551 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

1) Biochemical response (normalization of serum alanine aminotransferase activity)
2) Virological response (HCV-RNA <50IU per milliliter) at the end of treatment (week 48).

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Liver Cirrhosis
Chronic Hepatitis C

Intervention ^ICMJE

Drug: peginterferon alfa-2a 180μg
180μg（s.c.）/week for 48 weeks
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

Study Arm (s)

Experimental: 1
Interventions:
- Drug: peginterferon alfa-2a 180μg
- Drug: ribavirin
Experimental: 2
Interventions:
- Drug: peginterferon alfa-2a 90μg
- Drug: ribavirin
No Intervention: 3

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

180

Completion Date

June 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00304551

Other Study ID Numbers ^ICMJE

JV19595

Has Data Monitoring Committee

Responsible Party

Chugai Pharmaceutical

Study Sponsor ^ICMJE

Chugai Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Takehiko Aoshima

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

Information Provided By

Chugai Pharmaceutical

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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