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| 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 |
| MedlinePlus related topics: | Hepatitis Hepatitis C |
| Drug Information available for: | Interferon alfa-2b Interferons |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| United Therapeutics |
| Study Director: | Katrina L Swartz, PA-C, MHS | United Therapeutics |
More Information
trial listing service with patient screener and call center 
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| Study ID Numbers: | UT-231B-02:01 |
| First Received: | September 29, 2003 |
| ClinicalTrials.gov Identifier: | NCT00069511 |
| Health Authority: | United States: Food and Drug Administration |
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