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

Information source: Biolex Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: Locteron (controlled-release interferon alpha 2b) (Other); pegylated IFNa2b (Biological)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Biolex Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Walker Long, MD, Study Director, Affiliation: Biolex Therapeutics, Inc.

Summary

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-naďve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.

Clinical Details

Official title: An Open-Label, 3-Panel, Dose-Escalation Study to Assess the Safety and Tolerability, Pharmacokinetics, and Viral Kinetics of Two Doses of LocteronTM (Poly ActiveTM - Interferon Alpha 2b) Given Every 2 Weeks for 4-12 Weeks in Comparison With PEG-Intron Given Weekly for 4-12 Weeks in Patients With Chronic Hepatitis C

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: 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

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Henry Ford Hospital, Detroit, Michigan 48202, United States

Methodist Dallas Medical Center, Dallas, Texas 75208, United States

Alamo Medical Research, San Antonio, Texas 78215, United States

Inova Center for Liver Diseases, Annandale, Virginia 22003, United States

McGuire DVAMC, McGuire Research Institute, Richmond, Virginia 23249, United States

Additional Information

Starting date: January 2008
Last updated: February 1, 2012

Page last updated: August 23, 2015

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