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A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype

Principal Investigator:   Albert Min, MD
Time frame of study:   Closed to enrollment, subjects still active
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 12-week regimen of Telaprevir, Peg-IFN, and Ribavirin (RBV) is in treating subjects who have either never had treatment or have previously had treatment but the virus has returned. Enrollment is limited to subjects with specific types of Hepatitis. Patients enrolled in the study will receive Telaprevir in combination with Peg-IFN/RBV. At week 12, patients who have a response (rapid viral response) and completed the planned 12 weeks of treatment with Telaprevir and Peg-IFN/RBV will be randomized to either no further treatment with Peg-IFN/RBV or a further 12 weeks of treatment with Peg-IFN/RBV. All other patients will have a Peg-IFN/RBV treatment that is designed based on the patient’s response. All patients will have safety and virologic follow-up visits after the end of planned treatment duration. 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 and IL28B CC Genotype

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