Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Daclatasvir; Sofosbuvir; Ribavirin
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial was open to participants who had received a liver transplant or had cirrhosis due
      to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were
      followed for 24 weeks post treatment. Under certain conditions, the treatment duration could
      have been extended for cirrhotic participants. The study tested the efficacy and safety of
      this combination for treatment of HCV in cirrhotic and post transplant patients.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants must be able to understand and agree to comply with the prescribed dosing
             regimens and procedures, report for regularly scheduled study visits, and reliably
             communicate with study personnel about adverse events and concomitant medications

          -  Participants chronically infected with hepatitis C virus (HCV) Genotype 1, 2, 3, 4, 5,
             or 6 with HCV RNA viral load of ≥10,000 IU/mL at screening

          -  Participants may be treatment-naïve or treatment-experienced

          -  Cirrhotic participants must have cirrhosis confirmed by biopsy, Fibroscan or fibrotest
             and Aspartate aminotransferase platelet ratio index (APRI) criteria as outlined in the
             protocol

          -  Post-transplant participants must be at least 3 months post-transplant with no
             evidence of moderate or severe rejection

        Exclusion Criteria:

          -  History of multi-organ transplant, with the exception of dual transplantation of the
             liver/kidney, is prohibited

          -  Current or known history of cancer (with the following exceptions: In situ carcinoma
             of the cervix, adequately treated basal or squamous cell carcinoma of the skin, or
             hepatocellular carcinoma within Milan criteria for transplantation) within 5 years
             prior to screening

          -  Evidence of an ongoing medical condition contributing to chronic liver disease other
             than HCV (such as, but not limited to: hemochromatosis, autoimmune hepatitis,
             metabolic liver disease, alcoholic liver disease, or toxin exposures)

          -  History of HIV infection or chronic hepatitis B virus (HBV) as documented by HBV
             serologies (e.g., HBsAg-seropositive). Participants with resolved HBV infection may
             participate (e.g., HBcAb-seropositive with concurrent HBsAg-seronegative)

          -  Active hospitalization for decompensated liver disease