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
ClinicalTrials.gov Identifier:
NCT01979939
First Posted: November 8, 2013
Last Update Posted: November 3, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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
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| 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
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): NCT01979939
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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 ) |
| First Submitted: | November 4, 2013 |
| First Posted: | November 8, 2013 |
| Last Update Posted: | November 3, 2015 |
| Last Verified: | October 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 |