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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2004 by Unither Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Unither Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00069511
First received: September 29, 2003
Last updated: June 23, 2005
Last verified: June 2004
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Unither Pharmaceuticals:

Estimated Enrollment: 72
Study Start Date: July 2003
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069511

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
Sponsors and Collaborators
United Therapeutics
Investigators
Study Director: Katrina L Swartz, PA-C, MHS United Therapeutics
  More Information

Additional Information:
Publications:
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.
McHutchison, JG, Advances in Liver Disease: Hepatitis C. J Gastroenterol & Hepatol. 2002;17: 431-441.

ClinicalTrials.gov Identifier: NCT00069511     History of Changes
Other Study ID Numbers: UT-231B-02:01
Study First Received: September 29, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Unither Pharmaceuticals:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014