Decision of investigator
METFOVIR
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
Sponsor study identifier
interventional
11
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2014
Actual (reported)December 18, 2014
Actual (reported)June 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 2016
Actual (reported)April 2016
Actual (reported)rate of HCC occurrence and liver related-death or transplantation.
at 6 months
occurrence of liver-related complications (Ascites , gastrointestinal bleeding, encephalopathy)
at 6 months
1000 mg (2x500 mg) at morning and 1000 mg (2x500 mg) at afternoon (2000 mg per day) Metformin daily during 36 months
2 tablets at morning and 2 tablets at afternoon 4 tablets per day
1000 mg (2x500 mg) at morning and 1000 mg (2x500 mg) at afternoon (2000 mg per day) Metformin daily during 36 months
4 tablets per day for 36 months
Roulot Dominique
Bobigny, 93009, France
Nkontchou 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.
Sangiovanni 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.
Dominique Roulot, MD
Hospital Avicenne
11 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2014
First Posted
December 18, 2014
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
The Metformin Active Surveillance Trial (MAST) Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
N'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.
Perseghin 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.
Goodwin 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.
Nkontchou 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.
Salmon D, Bani-Sadr F, Loko MA, Stitou H, Gervais A, Durant J, Rosenthal E, Quertainmont Y, Barange K, Vittecoq D, Shoai-Tehrani M, Alvarez M, Winnock M, Trinchet JC, Dabis F, Sogni P. Insulin resistance is associated with a higher risk of hepatocellular carcinoma in cirrhotic HIV/HCV-co-infected patients: results from ANRS CO13 HEPAVIH. J Hepatol. 2012 Apr;56(4):862-8. doi: 10.1016/j.jhep.2011.11.009. Epub 2011 Dec 13.
Svegliati-Baroni G, Faraci G, Fabris L, Saccomanno S, Cadamuro M, Pierantonelli I, Trozzi L, Bugianesi E, Guido M, Strazzabosco M, Benedetti A, Marchesini G. Insulin resistance and necroinflammation drives ductular reaction and epithelial-mesenchymal transition in chronic hepatitis C. Gut. 2011 Jan;60(1):108-15. doi: 10.1136/gut.2010.219741. Epub 2010 Oct 21.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
January 11, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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