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Trial record 1 of 1 for:    Hepatitis C AND UT 231B
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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 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. Identifier: NCT00069511
Recruitment Status : Unknown
Verified June 2004 by Unither Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2003
Last Update Posted : June 24, 2005
Information provided by:
Unither Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Drug: UT-231B Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 2003
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00069511

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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
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
United Therapeutics
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Study Director: Katrina L Swartz, PA-C, MHS United Therapeutics
Additional Information:
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.

Layout table for additonal information Identifier: NCT00069511    
Other Study ID Numbers: UT-231B-02:01
First Posted: September 30, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2004
Keywords provided by Unither Pharmaceuticals:
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections