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Phase 2B Dose Ranging Study of Locteron Plus Ribavirin to Treat HCV

NCT00863239 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2012-02-02

No results posted yet for this study

Summary

The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

ribavirin

Co-administered in all arms: oral ribavirin, 200 mg capsules. Subjects with body weight \< 65 kg: 800 mg/day; Subjects with body weight 65-85 kg: 1000 mg/day; Subjects with body weight \> 85 kg: 1200 mg/day.

DRUG

Locteron™ (controlled-release interferon alpha 2b)

investigational controlled-release recombinant interferon alpha 2b formulated in 1500/77/23 PolyActive microspheres as a lyophilized powder, reconstituted with carboxymethyl cellulose immediately before subcutaneous injection every other week as part of the treatment of chronic hepatitis C

DRUG

PEG-Intron™

commercially available pegylated interferon alpha 2b injected subcutaneously weekly in a dose of 1.5 ug/kg as part of the treatment of chronic hepatitis C

Sponsors & Collaborators

  • Biolex Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Walker A. Long, MD · Biolex Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-11-30
Completion
2011-11-30

Countries

  • United States
  • Bulgaria
  • Puerto Rico
  • Romania

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 NCT00863239 on ClinicalTrials.gov