Project Title: 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-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1
Purpose: To evaluate the safety and efficacy of alb-IFN given with Ribavirin compared to IFN-alfa 2a/2b plus ribavirin (the standard of care)
Inclusion Criteria:
Naïve Compensated cirrhotics permitted if:
Sponsor:
Human Genome Sciences
Principal Investigator:
Steve Flamm, M.D.
Cost: no cost to patient
Contact:
Kim Sipich (312) 503-0121
Project Title: Comparison of Weight-based Doses of Taribavirin Combined With Peginterferon Alfa 2b Versus Ribavirin Combined With Peginterferon Alfa-2b in Therapy-naïve Patients With Chronic Hepatitis C Virus Genotype 1 Infection
Purpose: To evaluate the safety and efficacy of Taribavirin when given with IFN-alfa 2b vs. ribavirin given with IFN-alfa 2b (the standard of care)
Inclusion Criteria:
Naïve No cirrhotics
Sponsor:
Valeant Pharmaceuticals
Principal Investigator:
Steve Flamm, M.D.
Cost: no cost to patient
Contact:
Kim Sipich (312) 503-0121
Project Title:
Long-Term Follow-up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C (P05063)
Purpose:
To monitor for possible mutation variants in the body in patients previously treated with SCH 503034, a protease inhibitor.
Sponsor:
Schering Plough Research Institute
Principal Investigator:
Steven Flamm, M.D.
Cost:
None
Contact:
Kim Sipich (312) 503-0121
Project Title:
A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
Purpose:
To evaluate the safety and efficacy of a protease inhibitor given with IFN-alfa 2b and ribavirin.
Inclusion Criteria:
Naïve No cirrhotics
Sponsor:
Schering Plough Research Institute
Principal Investigator:
Steven Flamm, M.D.
Cost:
no cost to patient
Contact:
Noreen Khan (312) 503-0122
