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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.

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ClinicalTrials.gov 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

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

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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 ClinicalTrials.gov identifier (NCT number): NCT00069511

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
Study Director: Katrina L Swartz, PA-C, MHS United Therapeutics

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.

ClinicalTrials.gov Identifier: NCT00069511     History of Changes
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:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections