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 no longer recruiting patients.
| Sponsored by: |
United Therapeutics |
| 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
|
Treatment or Intervention |
Phase |
Hepatitis C
|
Drug: UT-231B
|
Phase II
|
MedlinePlus related topics: Hepatitis C
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Study Details:
Expected Total Enrollment:
72
Study start: July 2003;
Study completion: December 2004
Eligibility
Ages Eligible for Study:
18 Years
-
65 Years,
Genders Eligible for Study:
Both
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:
Location
Information
Florida Shands Hospital at the University of Florida, Gainesville,
Florida,
32610-0214,
United States
Louisiana Tulane Univ. Health Sciences Center, New Orleans,
Louisiana,
70112,
United States
Massachusetts Beth Israel Deaconess Medical Center, Boston,
Massachusetts,
02215,
United States
North Carolina UNC Hospital, Chapel Hill,
North Carolina,
27599,
United States
Tennessee Memphis Gastroenterology Group, Memphis,
Tennessee,
38120,
United States
Virginia VCU/MCV, Richmond,
Virginia,
23298,
United States
Study chairs or principal investigators
Katrina L Swartz, PA-C, MHS, Study Director, United Therapeutics
More Information
trial listing service with patient screener and call center
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
Record last reviewed:
June 2004
Record first received:
September 29, 2003
ClinicalTrials.gov Identifier:
NCT00069511Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-22
