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

This study is ongoing, but not recruiting participants.

First Received: September 29, 2003 Last Updated: History of Changes

Sponsored by:	United Therapeutics
Information provided by:	Unither Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00069511

Purpose

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.

Condition	Intervention	Phase
Hepatitis C	Drug: UT-231B	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Further study details as provided by Unither Pharmaceuticals:

Estimated Enrollment:	72
Study Start Date:	July 2003
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069511

Locations

United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610-0214
United States, Louisiana
Tulane Univ. Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, North Carolina
UNC Hospital
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Memphis Gastroenterology Group
Memphis, Tennessee, United States, 38120
United States, Virginia
VCU/MCV
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

United Therapeutics

Investigators

Study Director:

Katrina L Swartz, PA-C, MHS

United Therapeutics

More Information

Additional Information:

trial listing service with patient screener and call center This link exits the ClinicalTrials.gov site

Publications:

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

Durantel D, Branza-Nichita N, Carrouee-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.

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.

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.

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.

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.

Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. Review. No abstract available.

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.

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

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.

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, Goncales FL Jr, Haussinger 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.

McHutchison, JG, Advances in Liver Disease: Hepatitis C. J Gastroenterol & Hepatol. 2002;17: 431-441.

Study ID Numbers:	UT-231B-02:01
Study First Received:	September 29, 2003
ClinicalTrials.gov Identifier:	NCT00069511 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Unither Pharmaceuticals:

Hepatitis C

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Interferons
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases

Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C

ClinicalTrials.gov processed this record on July 02, 2009