4-Methylumbelliferone as a Treatment for Chronic HBV/HCV

Status unconfirmed · Phase 2

Conditions studied: Chronic Hepatitis C, Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT00225537

Run by

MTmedical Institute of Health

People needed

160

Starts

2005-09-01

Expected to finish

2007-08-01

Last updated by the study team

2006-09-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Serum ALT at least 1.5x the upper limit of normal
• For chronic HBV: Known positive serum HBeAg for at least 6 months; Presence of HBV DNA in serum
• For chronic HCV: Presence of anti-HCV in serum within 6 months of enrollment; Positive serum HCV RNA (enrollment)
• Written informed consent

You may not qualify if…

• Treatment (within past 3 months) with interferon, ribavirin, lamivudine, entecavir, or adefovir dipivoxil
• Current treatment with any drug or dietary supplement that could affect serum transaminase values (e.g., milk thistle)
• Pregnancy or inability to practice contraception in patients capable of bearing or fathering children
• Decompensated liver disease (as indicated by total bilirubin >4 mg/dL; albumin <3 g/dL; prolonged (>2 sec over control) prothrombin time; or history of bleeding esophageal varices, ascites or hepatic encephalopathy)
• Active alcohol use, drug abuse, and/or psychiatric problems that, in the investigator's opinion, could interfere with participation in the study
• Hepatitis D infection (for HBV-infected patients)

Where it is running

• University Health Center Downtown "Brady/Green", 527 North Leona, — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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