NCT00402428

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

Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,331 (actual)
• Sponsor: Human Genome Sciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2006-11-22
• Last updated: 2013-08-08

Locations

165 sites across 15 countries: United States, Australia, Austria, Canada, Czechia, France, Germany, India, Israel, Italy, Poland, Puerto Rico, Romania, Spain, United Kingdom