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

Biolex Therapeutics, Inc.32 enrolled

Overview

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.

Panels A and B of the PLUS study were designed to assess the safety and tolerability, pharmacokinetics, and viral kinetics over four weeks of two doses of Locteron™ (230 ug and 640 ug) given every two weeks in comparison with PegIntron® given weekly in treatment-experienced subjects with chronic hepatitis C of any genotype who were co-administered weight-based oral ribavirin. The two cohorts of 16 subjects each in Panels A and B consisted of subjects who had failed prior interferon therapy. In Panel A, 8 subjects were randomized to and completed 4 weeks of treatment with 320 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. In Panel B, 8 subjects were randomized to and completed 4 weeks of treatment with 640 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. When the results of Panel A and Panel B were known, conduct of Panel C for 12 weeks in treatment-naive patients with chronic genotype-1 HCV was considered unnecessary and cancelled, and an entirely new study was begun instead.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

Locteron (controlled-release interferon alpha 2b)OTHER

biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection

pegylated IFNa2bBIOLOGICAL

biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Evidence of chronic hepatitis C * Positive HCV RNA test with a level \>= 1 x 104 IU/mL (by RT-PCR) Exclusion Criteria: * 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

Locations (5)

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

Outcomes

Primary Outcomes

To assess in subjects with chronic hepatitis C the safety and tolerability of Locteron in comparison with PEG-Intron.

Time frame: 7 months (4 weeks of treatment, 6 months of follow up)

Secondary Outcomes

To assess in subjects with chronic hepatitis C receiving a weight-based oral daily dose of ribavirin: • The PK profile of Locteron (IFNa2b) • The preliminary efficacy of Locteron assessed by serial quantitation of HCV RNA levels

Time frame: 4 weeks

Data from ClinicalTrials.gov

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