Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

Phase 2

• Conditions: Chronic Hepatitis c; Insulin Resistance
• Interventions: Drug: metformin; Drug: pegylated-IFN; Drug: ribavirin

• Registration Number: NCT01664845
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).

Detailed Description

Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-13
• Last Update Submitted: 2012-08-13
• Study First Posted: 2012-08-14
• Last Update Posted: 2012-08-14
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• HCV RNA (+) and ALT > 40 U/L
• Compensated liver
• HOMA-IR > 2

Exclusion Criteria

• neutrophil <1500/mm3
• male: Hb < 13 g/dl, female: Hb < 12 g/dl
• platelet < 80,000 /mm3
• Cr > 2.5 mg/dl
• Alcohol use > 20 gm per day
• uncontrolled depression, thyroid disease, autoimmune disease
• Pregnancy
• Hepatocellular carcinoma
• allergy to interferon or ribavirin
• Diabetes
• HBV/HIV co-infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin, pegylated-IFN, ribavirin	pegylated-IFN	metformin,pegylated-IFN and ribavirin
metformin, pegylated-IFN, ribavirin	ribavirin	metformin,pegylated-IFN and ribavirin
Pegylated-IFN and ribavirin	pegylated-IFN	pegylated -IFN and ribavirin
metformin, pegylated-IFN, ribavirin	metformin	metformin,pegylated-IFN and ribavirin
Pegylated-IFN and ribavirin	ribavirin	pegylated -IFN and ribavirin

Primary Outcome Measures

Name	Time	Method
sustained virological response	24 weeks after treatment is stopped	HCV RNA negative 24 weeks after treatment is stopped

Secondary Outcome Measures

Name	Time	Method
change of HOMA-IR	Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment	Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan