4-Methylumbelliferone as a Treatment for Chronic HBV/HCV
|ClinicalTrials.gov Identifier: NCT00225537|
Recruitment Status : Unknown
Verified April 2006 by MTmedical Institute of Health.
Recruitment status was: Active, not recruiting
First Posted : September 23, 2005
Last Update Posted : September 11, 2006
Open-label studies, anecdotal reports, and in vitro scientific research indicate that 4-methylumbelliferone (active ingredient of the dietary supplement Heparvit®) may prevent and reverse the symptoms and complications of chronic infection with hepatitis B virus (HBV)and hepatitis C virus (HCV). This effect has been observed among naïve patients as well as those who are non-responders to interferon, commonly used as first-line therapy for HBV and HCV. In order to scientifically address the efficacy of this 4-methylumbelliferone on chronic viral hepatitis, a randomized, placebo-controlled, blinded study is needed.
It is hypothesized that 4-methylumbelliferone may reduce the impact and aggressiveness of HBV and HCV upon the liver, thereby slowing the progression to potentially life threatening liver diseases such as cancer and cirrhosis. This is a preliminary study designed to determine any indications under controlled conditions that may warrant further detailed clinical studies.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Chronic Hepatitis B||Drug: 4-Methylumbelliferone (Heparvit®)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Evaluation of 4-Methylumbelliferone for Treatment of Chronic Hepatitis B (HBV) and Chronic Hepatitis C (HCV)|
|Study Start Date :||September 2005|
|Estimated Study Completion Date :||August 2007|
- Reduction of virus in blood to undetectable levels;
- Normalization of serum ALT and AST.
- Reduced viral loads; Improvement of serum ALT and AST;
- Improvement in general health status;
- Improvement in serum marker of hepatic fibrosis;
- Loss of HBeAg/seroconversion to HBeAb (for HBV patients).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225537
|United States, Texas|
|University Health Center Downtown "Brady/Green", 527 North Leona,|
|San Antonio, Texas, United States, 78207|
|Principal Investigator:||Charles T Leach, Prof. M.D.||University of Texas Health Science Center : Department of Pediatrics|
|Principal Investigator:||Anastacio M Hoyumpa, Prof. M.D.||University of Texas Health Science Center : Medicine -Gastroenterolog|
|Study Director:||Dubravko Pavlin, PhD||University of Texas Health Science Center San Antonio|