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

NCT00593151 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-02-03

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

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

Sponsors & Collaborators

  • Biolex Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Walker Long, MD · Biolex Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-12-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593151 on ClinicalTrials.gov