Clinical trial · Interventional
Primary Prevention Hepatocellular Carcinoma by Metformin
PRIMARY PREVENTION OF HEPATOCELLULAR CARCINOMA BY METFORMIN IN PATIENTS WITH VIRAL C CIRRHOSIS : PROSPECTIVE MULTICENTER STUDY, RANDOMIZED CONTROL TRIAL. Ancillary Study of the ANRS CO12 CirVir Cohort
NCT02319200CI-TRIAL-00025441METFOVIRterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decision of investigator
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
| Hepatitis C, Chronic | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| placebo tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- 1000 mg (2x500 mg) at morning and 1000 mg (2x500 mg) at afternoon (2000 mg per day) Metformin daily during 36 months
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- placebo tablet
- description
- 2 tablets at morning and 2 tablets at afternoon 4 tablets per day
- interventionNames
- Drug: placebo tablet
Primary outcomes (1)
- measure
- rate of HCC occurrence and liver related-death or transplantation.
- timeFrame
- at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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)
References
Publications (8)
- BACKGROUNDNkontchou G, Cosson E, Aout M, Mahmoudi A, Bourcier V, Charif I, Ganne-Carrie N, Grando-Lemaire V, Vicaut E, Trinchet JC, Beaugrand M. Impact of metformin on the prognosis of cirrhosis induced by viral hepatitis C in diabetic patients. J Clin Endocrinol Metab. 2011 Aug;96(8):2601-8. doi: 10.1210/jc.2010-2415. Epub 2011 Jul 13. PMID 21752887
- BACKGROUNDSangiovanni A, Prati GM, Fasani P, Ronchi G, Romeo R, Manini M, Del Ninno E, Morabito A, Colombo M. The natural history of compensated cirrhosis due to hepatitis C virus: A 17-year cohort study of 214 patients. Hepatology. 2006 Jun;43(6):1303-10. doi: 10.1002/hep.21176. PMID 16729298
- BACKGROUNDN'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrie N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181. PMID 19731239
- BACKGROUNDPerseghin G, Calori G, Lattuada G, Ragogna F, Dugnani E, Garancini MP, Crosignani P, Villa M, Bosi E, Ruotolo G, Piemonti L. Insulin resistance/hyperinsulinemia and cancer mortality: the Cremona study at the 15th year of follow-up. Acta Diabetol. 2012 Dec;49(6):421-8. doi: 10.1007/s00592-011-0361-2. Epub 2012 Jan 4. PMID 22215126
- BACKGROUNDGoodwin PJ, Ennis M, Pritchard KI, Trudeau ME, Koo J, Taylor SK, Hood N. Insulin- and obesity-related variables in early-stage breast cancer: correlations and time course of prognostic associations. J Clin Oncol. 2012 Jan 10;30(2):164-71. doi: 10.1200/JCO.2011.36.2723. Epub 2011 Dec 12. PMID 22162568
- BACKGROUNDNkontchou G, Bastard JP, Ziol M, Aout M, Cosson E, Ganne-Carrie N, Grando-Lemaire V, Roulot D, Capeau J, Trinchet JC, Vicaut E, Beaugrand M. Insulin resistance, serum leptin, and adiponectin levels and outcomes of viral hepatitis C cirrhosis. J Hepatol. 2010 Nov;53(5):827-33. doi: 10.1016/j.jhep.2010.04.035. Epub 2010 Jul 14.