NCT00225537

Evaluation of 4-Methylumbelliferone for Treatment of Chronic Hepatitis B (HBV) and Chronic Hepatitis C (HCV)

Status unknown Phase 2 Last updated 7 September 2006

What this trial tests

Phase 2 trial testing 4-Methylumbelliferone (Heparvit®) in Chronic Hepatitis C in 160 participants. Status unknown.

Timeline

1 September 2005

1 August 2007

Quick facts

Lead sponsor	MTmedical Institute of Health
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	160
Start date	1 September 2005
Estimated completion	1 August 2007
Sites	1 location across United States

Drugs / interventions tested

• 4-Methylumbelliferone (Heparvit®) — full drug profile →

Conditions studied

• Chronic Hepatitis C — all drugs for Chronic Hepatitis C →
• Chronic Hepatitis B — all drugs for Chronic Hepatitis B →

Sponsor

MTmedical Institute of Health

Who can join

Adults 18 to 65, any sex, with Chronic Hepatitis C or Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the tumor microenvironment in cancer: why hyaluronidase deserves a second look.
   Whatcott CJ, Han H, Posner RG, Hostetter G, et al · · 2011 · cited 170× · PMID 22053288 · DOI 10.1158/2159-8290.cd-11-0136
2. Antitumor activity of hyaluronic acid synthesis inhibitor 4-methylumbelliferone in prostate cancer cells.
   Lokeshwar VB, Lopez LE, Munoz D, Chi A, et al · · 2010 · cited 158× · PMID 20332231 · DOI 10.1158/0008-5472.can-09-3185
3. Orchestrating the Tumor Microenvironment to Improve Survival for Patients With Pancreatic Cancer: Normalization, Not Destruction.
   Whatcott CJ, Han H, Von Hoff DD. · · 2015 · cited 75× · PMID 26222082 · DOI 10.1097/ppo.0000000000000140
4. Inhibition of hyaluronan retention by 4-methylumbelliferone suppresses osteosarcoma cells in vitro and lung metastasis in vivo.
   Arai E, Nishida Y, Wasa J, Urakawa H, et al · · 2011 · cited 67× · PMID 22045192 · DOI 10.1038/bjc.2011.459
5. 4-Methylumbelliferyl glucuronide contributes to hyaluronan synthesis inhibition.
   Nagy N, Gurevich I, Kuipers HF, Ruppert SM, et al · · 2019 · cited 42× · PMID 30914479 · DOI 10.1074/jbc.ra118.006166
6. Crucial role of hyaluronan in neointimal formation after vascular injury.
   Kashima Y, Takahashi M, Shiba Y, Itano N, et al · · 2013 · cited 33× · PMID 23484050 · DOI 10.1371/journal.pone.0058760
7. Targeting the Tumor Extracellular Matrix by the Natural Molecule 4-Methylumbelliferone: A Complementary and Alternative Cancer Therapeutic Strategy.
   Vitale DL, Icardi A, Rosales P, Spinelli FM, et al · · 2021 · cited 30× · PMID 34676159 · DOI 10.3389/fonc.2021.710061
8. Tumor Microenvironment Remodeling by 4-Methylumbelliferone Boosts the Antitumor Effect of Combined Immunotherapy in Murine Colorectal Carcinoma.
   Malvicini M, Fiore E, Ghiaccio V, Piccioni F, et al · · 2015 · cited 22× · PMID 26105158 · DOI 10.1038/mt.2015.112