Hepatitis C Infection Clinical Trial
Official title:
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
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
PRIMARY OBJECTIVE:
I. To determine whether treatment with SAMe for 24 weeks reduces serum level of
alpha-fetoprotein (AFP) in patients with advanced liver disease due to chronic hepatitis C.
SECONDARY OBJECTIVE:
I. To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma
carboxyprothrombin (DCP) and alpha-fetoprotein-L3 (AFP-L3) in patients with advanced liver
disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).
II. To determine whether treatment with SAMe for 24 weeks alters biochemical markers of liver
disease (e.g., serum alanine aminotransferase [ALT], aspartate aminotransferase [AST],
albumin, or bilirubin, etc.) and hepatitis C viral load in patients with advanced liver
disease due to chronic hepatitis C (hepatitis C liver disease).
III. To determine whether treatment with SAMe for 24 weeks reduces serum levels of tumor
necrosis factor-alpha (TNF-alpha), plasma levels of malondialdehyde (MDA), 4-hydroxynonenal
(4-HNE) and urine levels of F2-isoprostane in patients with advanced liver disease due to
chronic hepatitis C (oxidative stress).
IV. To determine whether treatment with SAMe for 24 weeks reduces plasma levels of methionine
and homocysteine and increases plasma glutathione (GSH) and SAMe in patients with advanced
liver disease due to chronic hepatitis C (SAMe metabolites).
V. To determine the safety, tolerability and quality of life of SAMe treatment (up to 2,400
mg/day) for 24 weeks in patients with advanced liver disease due to chronic hepatitis C.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive SAMe orally (PO) twice daily (BID) for 24 weeks in the absence of
disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO once daily (QD) for weeks 1-4, PO BID for weeks 5-8, and
PO three times daily (TID) for weeks 9-24 in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks.
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