Status:
UNKNOWN
4-Methylumbelliferone as a Treatment for Chronic HBV/HCV
Lead Sponsor:
MTmedical Institute of Health
Collaborating Sponsors:
The University of Texas Health Science Center at San Antonio
BioMonde Preparations Limited
Conditions:
Chronic Hepatitis C
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
(i). Chronic hepatitis B Chronicity of HBV following acute infection is strongly age-related; the majority (90%) of infants acquiring HBV perinatally go on to develop chronic infection, while most pe...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00225537
Start Date
September 1 2005
End Date
August 1 2007
Last Update
September 11 2006
Active Locations (1)
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1
University Health Center Downtown "Brady/Green", 527 North Leona,
San Antonio, Texas, United States, 78207