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

NCT ID: NCT00593151

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-03-31

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

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A, C, 320 mcg

Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin.

Group Type: EXPERIMENTAL

Locteron (controlled-release interferon alpha 2b)

Intervention Type: OTHER

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

B, C, 640 mcg

Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin.

Group Type: EXPERIMENTAL

Locteron (controlled-release interferon alpha 2b)

Intervention Type: OTHER

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

A, B, C PEG

Weekly subcutaneous injections of 1.5 ug/kg PegIntron (12 kDalton pegylated interferon alpha 2b) with oral ribavirin.

Group Type: ACTIVE_COMPARATOR

pegylated IFNa2b

Intervention Type: BIOLOGICAL

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

Interventions

Locteron (controlled-release interferon alpha 2b)

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

Intervention Type: OTHER

pegylated IFNa2b

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

Intervention Type: BIOLOGICAL

Other Intervention Names

PolyActive-IFNa2b; BLX-883+PolyActive; PEG-Intron; PEG; 12 kDalton pegylated interferon alpha 2b

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biolex Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walker Long, MD

Role: STUDY_DIRECTOR

Biolex Therapeutics, Inc.

Locations

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

Countries

United States

References

Lawitz E, Younossi ZM, Shiffman M, Gordon S, Ghalib R, Long W, Muir A, McHutchison J. Randomized trial comparing systemic and local reactions to controlled-release interferon alpha2b and pegylated-interferon alpha2b in hepatitis C subjects who failed prior treatment. J Hepatology 50:S231 (abstract 628), 2009. (Presented to the 44th Annual Meeting Of The European Association for the Study of the Liver, April 22-26, 2009.)

Reference Type: RESULT

Other Identifiers

S07-200-02-003

Identifier Type: -

Identifier Source: org_study_id