MedTrace Logo

Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection

NCT00513461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-08-10

Study results available
· View outcomes & findings →

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

Conditions

  • Adult Primary Liver Cancer
  • Hepatitis C Infection

Interventions

DRUG

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

Given PO

OTHER

placebo

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

immunoenzyme technique

Correlative studies

OTHER

high performance liquid chromatography

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Chao Family Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • John Hoefs · Chao Family Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-08-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00513461 on ClinicalTrials.gov