4-Methylumbelliferone as a Treatment for Chronic HBV/HCV

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by MTmedical Institute of Health.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The University of Texas Health Science Center at San Antonio
BioMonde Preparations Limited
Information provided by:
MTmedical Institute of Health
ClinicalTrials.gov Identifier:
NCT00225537
First received: June 30, 2005
Last updated: September 7, 2006
Last verified: April 2006
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Chronic Hepatitis B
Drug: 4-Methylumbelliferone (Heparvit®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of 4-Methylumbelliferone for Treatment of Chronic Hepatitis B (HBV) and Chronic Hepatitis C (HCV)

Resource links provided by NLM:


Further study details as provided by MTmedical Institute of Health:

Primary Outcome Measures:
  • Reduction of virus in blood to undetectable levels;
  • Normalization of serum ALT and AST.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 160
Study Start Date: September 2005
Estimated Study Completion Date: August 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225537

Locations
United States, Texas
University Health Center Downtown "Brady/Green", 527 North Leona,
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
MTmedical Institute of Health
The University of Texas Health Science Center at San Antonio
BioMonde Preparations Limited
Investigators
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
  More Information

Publications:
1: Epidemiology and Prevention of Vaccine-Preventable Diseases, 7th ed, Eds W. Atkinson, C. Wolfe, 2003, Department of Health and Human Services, Centers for Disease Control and Prevention.
12: O’Kennedy R, Thornes RD, editors. Coumarins: Biology, Applications and Mode of Action. West Sussex, England: John Wiley & Sons; 1997. ISBN: 0-471-96997-4
20: Sun S, Kong LY, Zhang HQ, He SA, Niwa M. The asymmetric synthesis of linear dihydropyrano-coumarins for Alzheimer’s disease. Heterocycles 2004;63:271-82.

ClinicalTrials.gov Identifier: NCT00225537     History of Changes
Other Study ID Numbers: UTHSCSA 045-900-246
Study First Received: June 30, 2005
Last Updated: September 7, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by MTmedical Institute of Health:
hcv
hbv
methylumbelliferone
liver
hepatitis
viral
heparvit
hiv
aids

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis B
Hepatitis C, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on October 19, 2014