Primary Prevention Hepatocellular Carcinoma by Metformin
NCT02319200 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2017-01-11
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
Conditions
- Hepatocellular Carcinoma
- Hepatitis C, Chronic
- Cirrhosis
Interventions
- DRUG
-
1000 mg (2x500 mg) at morning and 1000 mg (2x500 mg) at afternoon (2000 mg per day) Metformin daily during 36 months
- DRUG
-
placebo tablet
4 tablets per day for 36 months
Sponsors & Collaborators
-
ANRS, Emerging Infectious Diseases
collaborator OTHER_GOV -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Dominique Roulot, MD · Hospital Avicenne
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 77 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
Countries
- France
Study Locations
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