Primary Prevention Hepatocellular Carcinoma by Metformin

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Metformin treatment during 36 months could be associated with decreased risk of HCC occurrence and liver related death in patients with compensated HCV cirrhosis and insulinoresistance.

This study is an ancillary of the observational study from the CIRVIR cohort in which more than 1200 patients with compensated HCV cirrhosis are currently included.

participating centers : 26

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age of 18 years or older

• Patients included in ANRS cohort CO12 CirVir

• Without Hepatic local lesion (s) suggestive of HCC in the inclusion

• No indication for liver transplantation at baseline

• Child Pugh A or B7 at inclusion

• Without co-infection with HIV or HBV

• No history of lactic acidosis or of lactic acidosis at inclusion

• Insulino-resistance: (HOMA ≥2), or Body mass index≥ 25 kg/m ² without diabetes, or untreated known diabetes with HbA1c < 7 %

• No treatment with Metformin or other oral hypoglycemic containing metformin within 30 days before enrollment

• Available healthcare insurance

• Signed written informed consent.

Exclusion Criteria:

• Patient under guardianship or homeless

• Pregnant or breast-feeding women

• Patients with severe disease (excluding HCV liver disease) may threaten short-term life

• Cirrhosis with Child Pugh score> 7

• An alcohol consumption, higher than 40g / day for men and 30g / day for women

• Type 1 diabetes

• Diabetes treated with metformin

• Diabetes not treated with metformin with HbA1c ≥ 7%

• Hypersensitivity / intolerance in biguanides

• Hypersensitivity to the active substance or to any of the excipients.

• Kidney failure defined by creatinine clearance less than 30 ml/ min (MDRD formula)