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: NCT02032901
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

Purpose

To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV Genotype 3 infection

Condition Intervention Phase
Hepatitis C
Drug: Daclatasvir
Drug: 
Sofosbuvir

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 Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

  • Proportion of treatment naive subjects with sustained virologic response 12 (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) at follow-up Week 12

  • Proportion of treatment experienced subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Safety measured by frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), Grade 3/4 AEs, and Grade 3/4 laboratory abnormalities [ Time Frame: Up to end of treatment (EOT) (Week 12) + 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 and 12; EOT; post-treatment Weeks 4 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 and 12; EOT ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve SVR12 by baseline cirrhosis (presence or absence) [ Time Frame: Post treatment Week 12 ] [ 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 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: A1:Daclatasvir + Sofosbuvir in treatment-naive 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: A2:Daclatasvir + Sofosbuvir in treatment-experienced 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032901

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: NCT02032901 History of Changes
Other Study ID Numbers: AI444-218
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

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