IRB-14-6332[Indep.IRB: New England IRB] A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naïve and Treatment Experienced Subjects with Genotype 3 Chronic Hepatitis C Infection [Protocol: AI444-218]

Trial ID:
IRB-14-6332
Paul Pockros
To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV Genotype 3 infection

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects 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
  • Subjects chronically infected with HCV genotype 3
  • Subjects who are HCV-Treatment-naive
  • Subjects who are HCV-treatment-experienced
    • Previous exposure to non-structural 5A (NS5A) inhibitors is prohibited
  • HCV RNA ≥ 10,000 IU/mL at Screening

Exclusion Criteria:

  • HCV Genotypes other than genotype (GT) -3 infection; mixed genotype infections are not permitted
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy