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UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

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ClinicalTrials.gov Identifier: NCT01979939
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
Study Start Date : December 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: A 1: DCV/ASV/BMS-791325 in treatment-naive subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
 Drug: DCV/ASV/BMS-791325
Experimental: A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
 Drug: DCV/ASV/BMS-791325


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 [ Time Frame: Post-Treatment Week 12 ]
    SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12


Secondary Outcome Measures :
  1. Proportion of subjects in the experienced cohort with SVR12 [ Time Frame: Follow up Week 12 ]
  2. 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) ]
  3. Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 ]
  4. Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort [ Time Frame: Up to post treatment week 4 (±7 days) ]
  5. Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort [ Time Frame: Up to post treatment week 4 (±7 days) ]
  6. Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort [ Time Frame: Up to post treatment week 4 (±7 days) ]
  7. Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b [ Time Frame: Post treatment week 12 ]
  8. Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) [ Time Frame: Post treatment week 12 ]
  9. Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis [ Time Frame: Post treatment week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (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:

  • Subjects chronically infected with HCV genotype 1
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
  • Treatment-experienced subjects are eligible

Exclusion Criteria:

  • Evidence of cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to enrollment
  • Documented or suspected HCC
  • Evidence of decompensated liver
Contacts and Locations
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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): NCT01979939


Locations
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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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01979939    
Other Study ID Numbers: AI443-102
2013-002468-20 ( EudraCT Number )
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
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
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic