NCT00593151

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Biolex Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Locteron (controlled-release interferon alpha 2b)	biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection
BIOLOGICAL	pegylated IFNa2b	biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2008-01-14
• Last updated: 2012-02-03

Locations

5 sites across 1 country: United States