Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C

Completed · Phase 1/Phase 2

Conditions studied: Hepatitis C

In brief

The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.

Key facts

Study ID

NCT00593151

Run by

Biolex Therapeutics, Inc.

People needed

32

Starts

2008-01-01

Expected to finish

2009-03-01

Last updated by the study team

2012-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of chronic hepatitis C
• Positive HCV RNA test with a level >= 1 x 104 IU/mL (by RT-PCR)

You may not qualify if…

• Decompensated Liver Disease
• Positive test for serum antibodies to the human immunodeficiency virus (HIV), hepatitis A (HAV-IgM), o hepatitis B (HBV- +Hepatitis B surface antigen)
• A history of severe psychiatric disease, including major depression
• A history of immunologically-mediated disease, COPD, severe asthma, severe cardiac disease, active cancer or cancer within last 5 years, seizures within the past 5 years or epilepsy, solid organ or bone marrow transplant, uncontrolled thyroid disease, or clinically significant retinopathy
• Pregnant or lactating females

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Inova Center for Liver Diseases — Annandale, Virginia, United States
• McGuire DVAMC, McGuire Research Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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