We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov Menu

4-Methylumbelliferone as a Treatment for Chronic HBV/HCV

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2006 by MTmedical Institute of Health.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: September 23, 2005
Last Update Posted: September 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
The University of Texas Health Science Center at San Antonio
BioMonde Preparations Limited
Information provided by:
MTmedical Institute of Health

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
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)

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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
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

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.
Asmuth DM, Nguyen HH, Melcher GP, Cohen SH, Pollard RB. Treatments for hepatitis B. Clin Infect Dis. 2004 Nov 1;39(9):1353-62. Epub 2004 Oct 12. Review.
Shaw T, Bowden S, Locarnini S. Chemotherapy for hepatitis B: new treatment options necessitate reappraisal of traditional endpoints. Gastroenterology. 2002 Dec;123(6):2135-40. Review.
Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. Review.
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
Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65.
Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, Häussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82.
Pearlman BL. Hepatitis C treatment update. Am J Med. 2004 Sep 1;117(5):344-52. Review.
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
Abate A, Dimartino V, Spina P, Costa PL, Lombardo C, Santini A, Del Piano M, Alimonti P. Hymecromone in the treatment of motor disorders of the bile ducts: a multicenter, double-blind, placebo-controlled clinical study. Drugs Exp Clin Res. 2001;27(5-6):223-31.
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
Müller MJ, Fenk A, Lautz HU, Selberg O, Canzler H, Balks HJ, von zur Mühlen A, Schmidt E, Schmidt FW. Energy expenditure and substrate metabolism in ethanol-induced liver cirrhosis. Am J Physiol. 1991 Mar;260(3 Pt 1):E338-44.
Fylaktakidou KC, Hadjipavlou-Litina DJ, Litinas KE, Nicolaides DN. Natural and synthetic coumarin derivatives with anti-inflammatory/ antioxidant activities. Curr Pharm Des. 2004;10(30):3813-33. Review.
Kawase M, Tanaka T, Sohara Y, Tani S, Sakagami H, Hauer H, Chatterjee SS. Structural requirements of hydroxylated coumarins for in vitro anti-Helicobacter pylori activity. In Vivo. 2003 Sep-Oct;17(5):509-12.
Lacy A, O'Kennedy R. Studies on coumarins and coumarin-related compounds to determine their therapeutic role in the treatment of cancer. Curr Pharm Des. 2004;10(30):3797-811. Review.
Kudo D, Kon A, Yoshihara S, Kakizaki I, Sasaki M, Endo M, Takagaki K. Effect of a hyaluronan synthase suppressor, 4-methylumbelliferone, on B16F-10 melanoma cell adhesion and locomotion. Biochem Biophys Res Commun. 2004 Sep 3;321(4):783-7.
Lopez-Gonzalez JS, Prado-Garcia H, Aguilar-Cazares D, Molina-Guarneros JA, Morales-Fuentes J, Mandoki JJ. Apoptosis and cell cycle disturbances induced by coumarin and 7-hydroxycoumarin on human lung carcinoma cell lines. Lung Cancer. 2004 Mar;43(3):275-83.
Rilla K, Pasonen-Seppänen S, Rieppo J, Tammi M, Tammi R. The hyaluronan synthesis inhibitor 4-methylumbelliferone prevents keratinocyte activation and epidermal hyperproliferation induced by epidermal growth factor. J Invest Dermatol. 2004 Oct;123(4):708-14.
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 Submitted: June 30, 2005
First Posted: September 23, 2005
Last Update Posted: September 11, 2006
Last Verified: April 2006

Keywords provided by MTmedical Institute of Health:

Additional relevant MeSH terms:
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

To Top