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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.

Primary Purpose

Hepatitis C

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
UT-231B
Sponsored by
United Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shands Hospital at the University of Florida
  • Tulane Univ. Health Sciences Center
  • Beth Israel Deaconess Medical Center
  • UNC Hospital
  • Memphis Gastroenterology Group
  • VCU/MCV

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 29, 2003
Last Updated
June 23, 2005
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00069511
Brief Title
12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2004
Overall Recruitment Status
Unknown status
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
United Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
UT-231B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrina L Swartz, PA-C, MHS
Organizational Affiliation
United Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0214
Country
United States
Facility Name
Tulane Univ. Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UNC Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
VCU/MCV
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://www.veritasmedicine.com
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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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