Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments daclatasvir, sofosbuvir, ribavirin
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date March 2014
End date November 2014
Trial size 110 participants
Trial identifier NCT02032875, AI444-215

Summary

This trial is open to patients with cirrhosis due to chronic HCV, and to patients 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 subjects. The study will test how well this combination of investigational drugs works to treat chronic HCV.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Daclatasvir (DCV) 60 mg, Sofosbuvir (SOF) 400 mg, and Ribavirin (RBV) [dose based on hemoglobin level] tablets orally once daily for 12 weeks
daclatasvir BMS-790052
sofosbuvir
ribavirin
(Experimental)
Cirrhotic subjects who undergo transplant while on study treatment may enter an additional Treatment Extension period (≥3 months Post-Transplant) DCV 60 mg, SOF 400 mg, and RBV (dose based on hemoglobin level) tablets orally once daily for 12 weeks
daclatasvir BMS-790052
sofosbuvir
ribavirin
(Experimental)
DCV 60 mg, SOF 400 mg, and RBV (dose based on hemoglobin level) tablets orally once daily for 12 weeks
daclatasvir BMS-790052
sofosbuvir
ribavirin
(Experimental)
All subjects who relapse post-treatment may be eligible for an additional Relapse Re-treatment period DCV 60 mg, SOF 400 mg, and RBV (dose based on hemoglobin level) tablets orally once daily for 24 weeks
daclatasvir BMS-790052
sofosbuvir
ribavirin

Primary Outcomes

Measure
Proportion of genotype (GT) -1 infected Cirrhotic subjects with sustained virologic response (SVR12)
time frame: Post treatment Week 12
Proportion of GT-1 infected Post-transplant subjects with SVR12
time frame: Post treatment Week 12

Secondary Outcomes

Measure
The proportion of subjects who achieve SVR12 rates in all Cirrhotic and Post-transplant subjects, respectively, regardless of infecting HCV genotype, and GT-2-6 independently
time frame: Post treatment Week 12
Safety measured by frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), Grade 3/4 AEs, and Grade 3/4 clinical laboratory abnormalities
time frame: Up to end of treatment (Week 12 of the treatment phase) + 7 days
The proportion of subjects who achieve HCV RNA < LLOQ-TD/TND
time frame: At Weeks: 1, 2, 4, 6, 8, 12 and EOT; post-treatment Weeks 4, 8 and 24
The proportion of subjects who achieve HCV RNA < LLOQ TND
time frame: At Weeks: 1, 2, 4, 6, 8, 12 and EOT
The proportion of subjects with CC or non-CC genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNPs) who achieve SVR12 in Cirrhotic and Post-transplant subjects respectively
time frame: Post treatment Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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 1, 2, 3, 4, 5, or 6 with HCV RNA viral load of ≥10,000 IU/mL at screening - Subjects may be treatment-naïve or treatment-experienced - Cirrhotic subjects must have cirrhosis confirmed by biopsy, Fibroscan or fibrotest and Aspartate aminotransferase platelet ratio index (APRI) criteria as outlined in the protocol - Post-transplant subjects 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). Subjects with resolved HBV infection may participate (e.g., HBcAb-seropositive with concurrent HBsAg-seronegative) - Active hospitalization for decompensated liver disease

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.