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Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients

NCT00402428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1331

Last updated 2013-08-08

No results posted yet for this study

Summary

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

albumin interferon alfa-2b

900 mcg or 1200mcg every two week for 48 weeks

DRUG

peginterferon alfa-2a

180 mcg once a week for 48 weeks

DRUG

Ribavirin

1000 mg/day(for subjects \<75kg) or 1200 mg/day (for subjects =,\> 75kg)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Human Genome Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Poland
  • Puerto Rico
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00402428 on ClinicalTrials.gov