Clinical Trial:

Hepatitis C and Compensated Cirrhosis Study

Full Name

Hepatitis C and Compensated Cirrhosis: A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Subjects with Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis (2_PRO00001435)

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 4 treatment groups. Two of the groups will be for participants who received prior treatment for their Hepatitis C (called “treatment experienced”). Two of the groups will be for participants who have not received prior treatment for their Hepatitis C (called “treatment naïve”). Two of the four study groups will also take the drug ribavirin (RBV), while the other two groups will take a placebo (a pill that looks like ribavirin but contains no active drug). Participants will be assigned to one of the 4 treatment groups based in part on their prior treatment history. Group 1 (Treatment Naïve Participants) will receive DCV+ASV+BMS-791325 in the form of a single tablet plus RBV placebo. The amount of the ribavirin placebo will depend on the participant’s weight, and the study doctor will tell the participant the amount they should take. Group 2 (Treatment Naïve Participants) will receive DCV+ASV+BMS-791325 and Ribavirin. The amount of ribavirin will depend on the participant’s weight, and the study doctor will tell them how much to take. Group 3 (Treatment Experienced Participants) will receive DCV+ASV+BMS-791325 plus RBV matching placebo. The amount of ribavirin the participant is to take will depend on their weight. The study doctor will tell the participant how much to take. Group 4 (Treatment Experienced Participants) will receive DCV+ASV+BMS-791325 plus ribavirin. The amount of ribavirin the participant will take depends on their weight. The study doctor will tell the participant how much to take. Participants in all 4 groups will take the study drugs for 12 weeks. They will then have visits for 24 weeks in the post-study treatment period to monitor their disease status and their response to the study drugs. The RBV will be blinded, meaning that neither the participant, nor the study doctor will know if the participant is receiving ribavirin or placebo. In an emergency, the study doctor can find out if the participant received ribavirin or placebo. 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 have compensated cirrhosis as defined in the protocol
  • 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