Clinical Trial:

Study of Hepatitis C in Non-cirrhotic Patients

Full Name

Hepatitis C Study: AI443-102- A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects with Genotype 1 Chronic Hepatitis C (2_PRO00001431)

Description

Participants will receive daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 in a fixed dose combination (all three drugs are included in one tablet. The tablet contains 30 mg of DCV, 200 mg of ASV, and 75 mg of BMS-791325). Participants will be randomly assigned to one of 2 treatment groups. One group will be for participants who received prior treatment for their Hepatitis C (called “treatment experienced”). The other group will be for participants who have not received prior treatment for their Hepatitis C (called “treatment naïve”). Group 1 (treatment naïve participants) will receive DCV+ASV+BMS-791325, and will take it for 12 weeks. Participants will then have visits for 24 weeks in the post-treatment period to monitor their disease status and response to the study drugs. Group 2 (treatment experienced participants) will receive DCV+ASV+BMS-791325, and will take it for 12 weeks. Participants will then have visits for 24 weeks in the post-treatment period to monitor their disease status and response to the study drugs. There is an optional pharmacogenetic research sub-study. Pharmacogenetic research uses DNA from healthy and ill people to study the causes of diseases, help understand how different individuals respond to drugs, and obtain information to help develop new methods to diagnose and treat diseases.

Eligibility

Inclusion Criteria
  • Must be chronically infected with Hepatitis C (genotype I)
  • Must not have had liver or any other organ transplant other than cornea or hair
  • Must not have a known history of cancer within 5 years prior to screening
Doctor(s) Running This Study

Specialties

  • Infectious Diseases
  • Internal Medicine

Area of focus i

  • Hepatitis Care
  • HIV Care
  • HIV Pre-exposure Prophylaxis (PrEP)
  • LGBTQ+ Patient Support
  • Transgender health

LVPG Cliniciani

Accepting New Patients