January 11, 2014

This study is not yet open for participant recruitment.

Verified January 2014 by Bristol-Myers Squibb

Sponsor: Bristol-Myers Squibb

Information provided by (Responsible Party): Bristol-Myers Squibb

ClinicalTrials.gov Identifier: NCT02032875
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

Purpose

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.

Condition Intervention Phase
Hepatitis C Drug: Daclatasvir
Drug: Sofosbuvir
Drug: Ribavirin
Phase 3

Study Type:
Interventional

Study Design:
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A Hepatitis C Liver Transplantation

Drug Information available for: Ribavirin

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

  • Proportion of genotype (GT) -1 infected Cirrhotic subjects with sustained virologic response (SVR12) [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) 12 weeks after end of treatment (EOT)

  • Proportion of GT-1 infected Post-transplant subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) 12 weeks after end of treatment (EOT)

Secondary Outcome Measures:

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve HCV RNA < LLOQ TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8, 12 and EOT ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm 1a: Daclatasvir and Sofosbuvir in Cirrhotic subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir
Experimental: Arm 1b: Daclatasvir+Sofosbuvir+Ribavirin(Relapse Re-treatment)
Cirrhotic subjects who undergo transplant while on study treatment may enter an additional Treatment Extension or Relapse Re-treatment period
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks. Ribavirin tablet daily dose of 1000 - 1200 mg orally in two divided doses for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir Drug: Ribavirin
Experimental: Arm 1c: Daclatasvir and Sofosbuvir (Treatment Extension)
Cirrhotic subjects who undergo transplant while on study treatment may enter an additional Treatment Extension or Relapse Re-treatment period
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir
Experimental: Arm 2: Daclatasvir and Sofosbuvir in Post-transplant subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir

Eligibility

Ages Eligible for Study:  18 Years and older
Genders Eligible for Study:  Both
Accepts Healthy Volunteers:  No

Criteria

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-na├»ve 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032875

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Study Director: Bristol-Myers Squibb  Bristol-Myers Squibb

More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032875 History of Changes
Other Study ID Numbers: AI444-215
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

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