Clinical trial NCT00069511: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Hepatitis C
Lead sponsor: Unither Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-09-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: New Orleans
country: United States
facility: Tulane Univ. Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Chapel Hill
country: United States
facility: UNC Hospital
state: North Carolina
city: Memphis
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Richmond
country: United States
facility: VCU/MCV
state: Virginia
Study officials:
affiliation: United Therapeutics
name: Katrina L Swartz, PA-C, MHS
role: STUDY_DIRECTOR
References:
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