NCT00411385

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 933 (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 2/3 who are IFNa treatment naive.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	albumin interferon alfa-2b	900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
DRUG	peginterferon alfa-2a	180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
DRUG	Ribavirin	800mg/day for 24 weeks

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-12-14
• Last updated: 2013-08-08

Locations

159 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Malaysia, Mexico, Poland, Puerto Rico, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom