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A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (UNITY 4)

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ClinicalTrials.gov Identifier: NCT02170727
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 16, 2019
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 20, 2014
First Posted Date  ICMJE June 23, 2014
Results First Submitted Date  ICMJE March 22, 2019
Results First Posted Date  ICMJE August 16, 2019
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE June 26, 2014
Actual Primary Completion Date June 12, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort [ Time Frame: Post treatment Week 12 ]
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Proportion of treated subjects with SVR12 in the naive cohort [ Time Frame: Post treatment Week 12 ]
Proportion of treated subjects with Sustained virologic response 12 (SVR12) in the naive cohort, defined as HCV RNA < LOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort [ Time Frame: Post treatment Week 12 ]
    Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).
  • Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment) ]
    Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
  • Percentage of Participants Who Achieved HCV RNA < LLOQ TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment) ]
    Percentage of treated participants with HCV RNA < LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
  • Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment [ Time Frame: Up to post treatment week 4 ]
    SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
  • Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline [ Time Frame: Up to post treatment week 4 ]
    Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.
  • Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b [ Time Frame: Post treatment week 12 ]
    Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
  • Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) [ Time Frame: Post treatment Week 12 ]
    Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
  • Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 [ Time Frame: Post treatment Week 12 ]
    Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
  • Number of Participants With Selected Grade 3/4 Laboratory Abnormalities [ Time Frame: Post treatment week 4 ]
    Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
  • Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs [ Time Frame: Up to post treatment week 4 ]
    Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
  • Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities [ Time Frame: Up to post treatment week 4 ]
    Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
  • Proportion of treated subjects with SVR12 in the IFNα experienced cohort [ Time Frame: Post treatment Week 12 ]
    Proportion of treated subjects with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND)
  • Proportion of subjects in each cohort who achieve HCV RNA < LOQ TD/TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) ]
  • Proportion of subjects in each cohort who achieve HCV RNA < LOQ TND [ Time Frame: Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12 and 24 ]
  • Safety in each cohort, as measured by frequency of serious adverse events(SAEs), discontinuations due to AEs, and selected Grade 3-4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) [ Time Frame: Up to post treatment week 4 ]
  • Proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who have Hb ≥10 g/dL at baseline in each cohort [ Time Frame: Up to post treatment week 4 ]
  • Proportion of subjects in each cohort achieving SVR12 associated with hepatitis C virus (HCV) genotype subtype 1a vs 1b [ Time Frame: Post treatment week 12 ]
  • Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) [ Time Frame: Post treatment Week 12 ]
  • Proportion of cirrhotic and non cirrhotic subjects who achieve SVR12 [ Time Frame: Post treatment Week 12 ]
  • Safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to adverse events (AEs), and selected Grade 3 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) [ Time Frame: Post treatment week 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Official Title  ICMJE A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Brief Summary To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
Detailed Description US National Institutes of Health Division of AIDs (DAIDS)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus
Intervention  ICMJE Drug: DCV/ASV/BMS-791325
Study Arms  ICMJE Experimental: Arm 1 : DCV/ASV/BMS-791325
DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Intervention: Drug: DCV/ASV/BMS-791325
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019)
199
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2014)
160
Actual Study Completion Date  ICMJE September 9, 2015
Actual Primary Completion Date June 12, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subject chronically infected with HCV genotype 1 (GT-1)
  • Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
  • Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV

Exclusion Criteria:

  • Liver or any other 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Russian Federation,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02170727
Other Study ID Numbers  ICMJE AI443-123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP