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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
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01979939
First received: November 4, 2013
Last updated: October 9, 2015
Last verified: October 2015
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Purpose
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
| Condition | Intervention | Phase |
|---|---|---|
| Hepatitis C | Drug: DCV/ASV/BMS-791325 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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:
- Proportion of subjects in the experienced cohort with SVR12 [ Time Frame: Follow up Week 12 ]
- 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: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 ]
- 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) ]
- 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) ]
- 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) ]
- Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b [ Time Frame: Post treatment week 12 ]
- 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 ]
- Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis [ Time Frame: Post treatment week 12 ]
| Enrollment: | 416 |
| Study Start Date: | December 2013 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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 Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01979939
Show 66 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01979939
Show 66 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01979939 History of Changes |
| Other Study ID Numbers: |
AI443-102 2013-002468-20 ( EudraCT Number ) |
| Study First Received: | November 4, 2013 |
| Last Updated: | October 9, 2015 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on August 18, 2017