12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.

Hepatitis C Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00069511
• Other study ID #: UT-231B-02:01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 29, 2003
• Last updated: June 23, 2005
• Start date: July 2003
• Est. completion date: December 2004

Study information

• Verified date: June 2004
• Source: Unither Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multi-center study. Neither the study subjects nor the physicians will know what treatment an individual subject is receiving. Subjects will be randomly assigned (like flipping a coin) to one of five treatment groups. The treatment groups include four different dosing groups of active study drug and one group of subjects who will receive placebo. A 12 week follow up period occurs after the 12 weeks of dosing. The study endpoint is a reduction in Hepatitis C viral load.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients must be adults,

• have a positive Hepatitis C antibody test,

• and be genotype 1, with a minimum of 100,000 IU of Hepatitis C virus by nucleic acid testing, be non-cirrhotic with a Metavir score of F0-3 (or equivalent) on liver biopsy, and have failed previous therapy with Interferon or Peg Interferon monotherapy, Interferon plus ribavirin, or Peg Interferon and ribavirin.

Exclusion Criteria:

• Diabetics are excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• UT-231B

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	UNC Hospital	Chapel Hill	North Carolina
United States	Shands Hospital at the University of Florida	Gainesville	Florida
United States	Memphis Gastroenterology Group	Memphis	Tennessee
United States	Tulane Univ. Health Sciences Center	New Orleans	Louisiana
United States	VCU/MCV	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (14)

Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. — View Citation

Chylack LT Jr, Wolfe JK, Singer DM, Leske MC, Bullimore MA, Bailey IL, Friend J, McCarthy D, Wu SY. The Lens Opacities Classification System III. The Longitudinal Study of Cataract Study Group. Arch Ophthalmol. 1993 Jun;111(6):831-6. — View Citation

Durantel D, Branza-Nichita N, Carrouée-Durantel S, Butters TD, Dwek RA, Zitzmann N. Study of the mechanism of antiviral action of iminosugar derivatives against bovine viral diarrhea virus. J Virol. 2001 Oct;75(19):8987-98. — View Citation

France MR. Hepatitis C Therapy 2002. Advance for Physician Assistants 2002;10:60-75.

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. — View Citation

Karbassi M, Khu PM, Singer DM, Chylack LT Jr. Evaluation of lens opacities classification system III applied at the slitlamp. Optom Vis Sci. 1993 Nov;70(11):923-8. — View Citation

Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. Review. — View Citation

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. — View Citation

McHutchison JG. Hepatitis C advances in antiviral therapy: what is accepted treatment now? J Gastroenterol Hepatol. 2002 Apr;17(4):431-41. Review. — View Citation

Pavlovic D, Neville DC, Argaud O, Blumberg B, Dwek RA, Fischer WB, Zitzmann N. The hepatitis C virus p7 protein forms an ion channel that is inhibited by long-alkyl-chain iminosugar derivatives. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6104-8. Epub 2003 Apr 28. — View Citation

Rosen HR, Martin P. Hepatitis B and C in the liver transplant recipient. Semin Liver Dis. 2000;20(4):465-80. Review. — View Citation

Ross RS, Viazov S, Sarr S, Hoffmann S, Kramer A, Roggendorf M. Quantitation of hepatitis C virus RNA by third generation branched DNA-based signal amplification assay. J Virol Methods. 2002 Mar;101(1-2):159-68. — View Citation

Schiff ER, McHutchison JG, Jacobson IM, Lindsay KL, Bacon BR, Maddrey WC. Confronting the Growing Threat of Hepatitis C: a New Call to Action. The Treatment Reporter: Gastroenterology. Secaucus, NJ: Projects in Knowledge Inc.; 2000.

Zeuzem S, Feinman SV, Rasenack J, Heathcote EJ, Lai MY, Gane E, O'Grady J, Reichen J, Diago M, Lin A, Hoffman J, Brunda MJ. Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med. 2000 Dec 7;343(23):1666-72. — View Citation

* Note: There are 14 references in all — Click here to view all references