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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304551
• Other study ID #: JV19595
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2006
• Last updated: June 1, 2010
• Start date: June 2006
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Drug:
• peginterferon alfa-2a 180µg
180µg(s.c.)/week for 48 weeks
• peginterferon alfa-2a 90µg
90µg(s.c.)/week for 48 weeks
• ribavirin
600, 800, or 1,000 mg X 2(p.o.)/day

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])		week 24 from the end of treatment	No
Secondary	Biochemical response (normalization of serum alanine aminotransferase activity)		at the end of treatment and week 24 form the end of treatment	No
Secondary	Virological response (HCV-RNA < 50 IU per milliliter)		at the end of treatment and week 24 form the end of treatment	No