CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
S-adenosyl-L-methionine disulfate p-toluene-sulfonate +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00513461
NCT00513461Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Controlled Trial of The Safety and Efficacy of S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) in Reducing Serum Alpha-Fetoprotein (AFP) in Patients With Hepatitis C and Moderately Elevated AFP

Chao Family Comprehensive Cancer Center·interventional·Posted Aug 8, 2007·Updated Aug 10, 2018

In Brief

A Phase 2 clinical trial evaluating S-adenosyl-L-methionine disulfate p-toluene-sulfonate, placebo, and 3 other interventions for Adult Primary Liver Cancer and Hepatitis C Infection. Completed, enrolled 110 participants across 5 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Primary Liver Cancer, Hepatitis C Infection
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2007
Enrollment StartOct 1, 2007
Primary CompletionAug 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.9 years ago

Interventions

S-adenosyl-L-methionine disulfate p-toluene-sulfonatedrug

Given PO

placeboother

Given PO

laboratory biomarker analysisother

Correlative studies

immunoenzyme techniqueother

Correlative studies

high performance liquid chromatographyother

Correlative studies