PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

Hepatitis C Virus Clinical Trial

Official title:

Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00956982
• Other study ID #: KULDS2009
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2009
• Last updated: August 10, 2009
• Start date: December 2004
• Est. completion date: December 2012

Study information

• Verified date: August 2009
• Source: Kyushu University
• Contact: Jun Hayashi
• Phone: +81-92-642-5909
• Email: hayashij[@]genmedpr.med.kyushu-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1251
• Est. completion date: December 2012
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.

• All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.

Exclusion Criteria:

• Clinical or biochemical evidence of hepatic decompensation.

• Advanced cirrhosis identified by large esophageal varices (F2 or F3).

• History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.

• Hemoglobin level < 11.5g/L, white blood cell count < 3×109/L,and platelet count < 50×109/L.

• Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).

• Excessive active alcohol consumption > 60 g/day or drug abuse.

• Severe psychiatric disease.

• Antiviral or corticosteroid therapy within 12 months prior to the enrollment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• Pegylated interferon alpha-2b plus ribavirin
All patients were treated with a weight-based, 1.5 µg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively

Locations

Country	Name	City	State
Japan	Department of General Medicine, Kyushu University Hospital	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kyushu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antiviral effect by PEG-IFN alpha-2b plus RBV treatment		24-weeks follow-up after the end of treatment	Yes
Secondary	the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment		during PEG-IFN alpha-2b plus RBV treatment (48 weeks)	No