4-Methylumbelliferone as a Treatment for Chronic HBV/HCV

NCT00225537 | Unknown Phase 2

• 1 other identifier: UTHSCSA 045-900-246
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C; Chronic Hepatitis B

Keywords

hcv; hbv; methylumbelliferone; liver; hepatitis; viral; heparvit; hiv; aids

Outcome Measures

Primary Outcomes (2)

• Reduction of virus in blood to undetectable levels;

• Normalization of serum ALT and AST.

Secondary Outcomes (4)

• 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).

Interventions

4-Methylumbelliferone (Heparvit®) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MTmedical Institute of Health: lead
• The University of Texas Health Science Center at San Antonio: collaborator
• BioMonde Preparations Limited: collaborator

Study Sites (1)

University Health Center Downtown "Brady/Green", 527 North Leona,

San Antonio, Texas, 78207, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis B, Chronic; Hepatitis C; Hepatitis B; Hepatitis; Acquired Immunodeficiency Syndrome

Interventions

Hymecromone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepadnaviridae Infections; DNA Virus Infections; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Umbelliferones; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Dubravko Pavlin, PhD

  University of Texas Health Science Center San Antonio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: September 23, 2005
• Study Start: September 1, 2005
• Study Completion: August 1, 2007
• Last Updated: September 11, 2006

Record last verified: 2006-04

Locations

US (1)