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 - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Daclatasvir

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b [ Time Frame: Post treatment week 12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis [ Time Frame: Post treatment week 12 ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979939

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Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

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

Poordad F, Sievert W, Mollison L, Bennett M, Tse E, Bräu N, Levin J, Sepe T, Lee SS, Angus P, Conway B, Pol S, Boyer N, Bronowicki JP, Jacobson I, Muir AJ, Reddy KR, Tam E, Ortiz-Lasanta G, de Lédinghen V, Sulkowski M, Boparai N, McPhee F, Hughes E, Swenson ES, Yin PD; UNITY-1 Study Group. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015 May 5;313(17):1728-35. doi: 10.1001/jama.2015.3860.


Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01979939 History of Changes
Other Study ID Numbers:	AI443-102 2013-002468-20
Study First Received:	November 4, 2013
Last Updated:	October 9, 2015
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 September 23, 2016