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

Chronic Hepatitis C Clinical Trial

Official title:

A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144469
• Other study ID #: JV15725
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: January 29, 2009
• Start date: May 2002
• Est. completion date: March 2005

Study information

• Verified date: January 2009
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a

• rivavirin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
Secondary	Biochemical response (normalization of serum alanine aminotransferase activity),
Secondary	Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.