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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

Study Description
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Brief Summary:
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: DCV/ASV/BMS-791325 Phase 3

Detailed Description:
US National Institutes of Health Division of AIDs (DAIDS)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Actual Study Start Date : June 26, 2014
Actual Primary Completion Date : June 12, 2015
Actual Study Completion Date : September 9, 2015

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Arms and Interventions
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Arm Intervention/treatment
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
 Drug: DCV/ASV/BMS-791325


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170727


Locations
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Korea, Republic of
Local Institution
Busan, Korea, Republic of, 602-739
Local Institution
Busan, Korea, Republic of, 614-735
Local Institution
Gyeonggi-do, Korea, Republic of, 463-707
Local Institution
Gyeonggi-Do, Korea, Republic of, 480-717
Local Institution
Gyeongsangnam-do, Korea, Republic of, 626-770
Local Institution
Inchoen, Korea, Republic of, 405-760
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of, 138-736
Local Institution
Seoul, Korea, Republic of, 156-755
Russian Federation
Local Institution
Kazan, Russian Federation, 420140
Local Institution
Moscow, Russian Federation, 109240
Taiwan
Local Institution
Kaohsiung, Taiwan, 807
Local Institution
Kaohsiung, Taiwan, 833
Local Institution
Taichung, Taiwan, 40447
Local Institution
Taichung, Taiwan, 40705
Local Institution
Tainan, Taiwan, 704
Local Institution
Taipei, Taiwan, 100
Local Institution
Taipei, Taiwan, 112
Local Institution
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02170727    
Other Study ID Numbers: AI443-123
First Posted: June 23, 2014    Key Record Dates
Results First Posted: August 16, 2019
Last Update Posted: October 29, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic