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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UT-231B | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrina L Swartz, PA-C, MHS | United Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610-0214 | United States | ||
| Tulane Univ. Health Sciences Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11200416 | Background | Rosen HR, Martin P. Hepatitis B and C in the liver transplant recipient. Semin Liver Dis. 2000;20(4):465-80. doi: 10.1055/s-2000-13156. | |
| 11533162 | Background | 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. doi: 10.1128/JVI.75.19.8987-8998.2001. |
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| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| UNC Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Memphis Gastroenterology Group | Memphis | Tennessee | 38120 | United States |
| VCU/MCV | Richmond | Virginia | 23298 | United States |
| 12719519 | Background | 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. doi: 10.1073/pnas.1031527100. Epub 2003 Apr 28. |
| 8512486 | Background | 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. doi: 10.1001/archopht.1993.01090060119035. |
| 8302528 | Background | 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. doi: 10.1097/00006324-199311000-00009. |
| 11849694 | Background | 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. doi: 10.1016/s0166-0934(01)00433-5. |
| 11439948 | Background | Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available. |
| 10451460 | Background | 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. doi: 10.1056/NEJM199908193410802. |
| Background | France MR. Hepatitis C Therapy 2002. Advance for Physician Assistants 2002;10:60-75. |
| Background | 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. |
| 11106715 | Background | 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. doi: 10.1056/NEJM200012073432301. |
| 11583749 | Background | 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. doi: 10.1016/s0140-6736(01)06102-5. |
| 12324553 | Background | 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. doi: 10.1056/NEJMoa020047. |
| 11982724 | Background | McHutchison JG. Hepatitis C advances in antiviral therapy: what is accepted treatment now? J Gastroenterol Hepatol. 2002 Apr;17(4):431-41. doi: 10.1046/j.1440-1746.2002.02777.x. |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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