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A Multicenter, Open-Label, Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple  Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis

Principal Investigator:   Albert Min, MD
Time frame of study:   Ongoing
Location of Study:   Mount Sinai Beth Israel
Contact name, number and email  

Duyang Kim at 212-844-6446 or dukim@chpnet.org


Summary:
The purpose of the study is to evaluate how effective a quadruple drug regimen [VX-222, Telaprevir, Peg-IFN, and Ribavirin (RBV)] is in treating subjects who have either never had treatment, have previously relapsed, or did not respond adequately to Peg-IFN and/or RBV therapy. Enrollment is limited to subjects with genotype 1 chronic hepatitis that also have cirrhosis.  Subjects will be given both VX-222, an investigational drug, and Telaprevir to increase the likelihood of a response. Enrolled subjects will receive the quadruple therapy for 12 weeks, followed by additional 12 weeks of Peg-IFN/RBV therapy. A small number of patients (less than 10) enrolled under previous versions of this protocol will receive the triple regimen (Telaprevir, peg-IFN, and RBV). All patients will have safety and virologic follow-up visits after completion of planned duration of treatment. Subjects will be reimbursed for travel and all research procedures, including drug, are covered by the sponsor


Eligibility Participants:

  • At least 18 years of age
  • Currently have Genotype 1 Chronic Hepatitis C
  • Currently have Cirrhosis

For additional information, or to participate, please contact Duyang Kim at 212-844-6446 or dukim@chpnet.org