Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513461
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2007-08-06
Brief Title:
Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection
Sponsor:
Chao Family Comprehensive Cancer Center
Organization:
University of California Irvine
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 eg 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 2400 mgday 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
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 eg 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 2400 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CN35160 | NIH | None | None |
| CDR0000558657 | REGISTRY | None | None |
| UCI04-3-01 | OTHER_GRANT | NCI | httpsreporternihgovquickSearchN01CN35160 |