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

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 June 2004 by Unither Pharmaceuticals.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00069511
First Posted: September 30, 2003
Last Update Posted: June 24, 2005
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.
Information provided by:
Unither Pharmaceuticals
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Unither Pharmaceuticals:

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

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

ClinicalTrials.gov Identifier: NCT00069511     History of Changes
Other Study ID Numbers: UT-231B-02:01
First Submitted: September 29, 2003
First Posted: September 30, 2003
Last Update Posted: June 24, 2005
Last Verified: June 2004

Keywords provided by Unither Pharmaceuticals:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections


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