Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection

Phase 2 Completed 110 enrolled Chao Family Comprehensive Cancer Center National Cancer Institute (NCI) · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients with chronic hepatitis C infection. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of SAMe may keep cancer from forming in patients with advanced liver disease

Timeline

Start: 2007-10
Primary completion: 2012-08
Completion: 2013-12

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm I (SAMe) vs Arm II (Placebo); p = 0.160; Mean Difference (Net) 7.78; Wilcoxon (Mann-Whitney) NCT00513461 ↗

paper There was no difference in the change in AFP during 24 weeks among subjects receiving SAMe as compared with placebo. PMID 26130251 ↗

Publications

Results Morgan TR, Osann K, Bottiglieri T, Pimstone N, Hoefs JC, Hu KQ, Hassanein T, Boyer TD, Kong L, Chen WP, Richmond E, Gonzalez R, Rodriguez LM, Meyskens FL. A Phase II Randomized, Controlled Trial of S-Adenosylmethionine in Reducing Serum alpha-Fetoprotein in Patients with Hepatitis C Cirrhosis and Elevated AFP. Cancer Prev Res (Phila). 2015 Sep;8(9):864-72. doi: 10.1158/1940-6207.CAPR-15-0029. Epub 2015 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	S-adenosylmethionine	Other / unclassified	2400 mg	Oral