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

Kaohsiung Veterans General Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Chronic Hepatitis c; Insulin Resistance

Treatments: Drug: pegylated-IFN; Drug: metformin; Drug: ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01664845

VGHKS12-CT3-16

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

metformin, pegylated-IFN, ribavirin

Active Comparator group

Description:

metformin,pegylated-IFN and ribavirin

Treatment:

Drug: metformin

Drug: pegylated-IFN

Drug: ribavirin

Pegylated-IFN and ribavirin

Placebo Comparator group

Description:

pegylated -IFN and ribavirin

Treatment:

Drug: pegylated-IFN

Drug: ribavirin