4-Methylumbelliferone as a Treatment for Chronic HBV/HCV

• Status: Unknown status
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MTmedical Institute of Health
• Collaborators: BioMonde Preparations Limited; The University of Texas Health Science Center at San Antonio

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)