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 - Northwestern Memorial Hospital - Chicago

Safety & Efficacy of alb-IFN with Ribavirin Compared to IFN-alfa 2a/2b Plus Ribavirin

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

The primary purpose of this study is 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:

  • GT 1 -ANC >1500/mm3
  • -PLT >90,000
  • -Hb >13g/dL males >12g/dL females
  • -AFP <20 ng/mL If >20, neg. imaging within 6 ms.

Sponsor:

Human Genome Sciences

Principle Investigator:

Steve Flamm, MD

Cost:

None

Contact:

Kim Sipich
312-503-0121

Last UpdateMarch 25, 2011
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