Overview

Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Ribavirin
Sofosbuvir
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