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4-Methylumbelliferone as a Treatment for Chronic HBV/HCV

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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
Sponsor:
Collaborators:
Information provided by:

Study Description
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 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Reduced viral loads; Improvement of serum ALT and AST;
  2. Improvement in general health status;
  3. Improvement in serum marker of hepatic fibrosis;
  4. Loss of HBeAg/seroconversion to HBeAb (for HBV patients).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
5: NIH Consensus Statement on Management of Hepatitis C: 2002. NIH Consens State Sci Statements 2002; June 10-12; 19(3):1-46. PMID: 12407572
9: Penn State College of Medicine. Hershey, PA: 2004. Cited 2004 Dec 29. Faculty Research Expertise Database. Available from: http://fred.hmc.psu.edu/ds/retrieve/fred/meshdescriptor/D014468
10: Penn State College of Medicine. Hershey, PA: 2004. Cited 2004 Dec 29. Faculty Research Expertise Database. Available from: http://fred.hmc.psu.edu/ds/retrieve/fred/meshdescriptor/D006923
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
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: April 2006

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