MedTrace Logo

480 STUDY: Phase 2b Study of Locteron Plus Ribavirin to Treat Hepatitis C Virus (HCV)

NCT00953589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-02-02

No results posted yet for this study

Summary

The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5 ug/kg PEG-Intron™ dosed weekly.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

ribavirin

Ribavirin - oral administration Subjects with body weight \< 65 kg: 800 mg/day Subjects with body weight 65-85 kg: 1000 mg/day Subjects with body weight 86-105 kg: 1200 mg/day Subjects with body weight \> 105 kg: 1400 mg/day

Sponsors & Collaborators

  • Biolex Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Walker A. Long, MD · Biolex Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-05-31
Completion
2011-01-31

Countries

  • Bulgaria
  • Israel
  • Romania

Study Locations

More Related Trials

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 NCT00953589 on ClinicalTrials.gov