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



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:January 2016

Use our guide to learn which trials are right for you!

A Phase 3 Evaluation of Daclatasvir, Sofosbuvir, and Ribavirin in Genotype 1-6 Chronic Hepatitis C Infection Subjects With Cirrhosis Who May Require Future Liver Transplant and Subjects Post-Liver Transplant

This trial is open to participants with cirrhosis due to chronic hepatitis C virus (HCV),
and to participants who have already received a liver transplant for chronic HCV. All
subjects will be treated with Daclatasvir and Sofosbuvir for 12 weeks. Under certain
conditions, the treatment duration may be extended for cirrhotic participants . The study
will test how well this combination of investigational drugs works to treat chronic HCV.


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
We found this trial at
5
sites
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
?
mi
from
Seattle, WA
Click here to add this to my saved trials