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UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

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ClinicalTrials.gov Identifier: NCT01973049
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : October 9, 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 combination with or without Ribavirin in treatment naive cirrhotic subjects.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Daclatasvir Drug: Asunaprevir Drug: BMS-791325 Drug: Ribavirin Drug: Placebo matching Ribavirin Phase 3

Detailed Description:
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
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

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive)

Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks

 Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Drug: BMS-791325 Drug: Placebo matching Ribavirin
Experimental: A2: DCV/ASV/BMS-791325 + RBV (naive)

Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Ribavirin 200mg tablet orally twice a day for 12 weeks

 Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Drug: BMS-791325 Drug: Ribavirin
Other Name: Ribasphere®
Experimental: A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)

Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks

 Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Drug: BMS-791325 Drug: Placebo matching Ribavirin
Experimental: A4: DCV/ASV/BMS-791325 + RBV (experienced)

Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If < 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if ≥ 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening

 Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Drug: BMS-791325 Drug: Ribavirin
Other Name: Ribasphere®


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) [ Time Frame: Post treatment 12 week ]
    SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) < Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)


Secondary Outcome Measures :
  1. Proportion of treated subjects in each of the experienced arms with SVR12 [ Time Frame: Post treatment 12 Week ]
  2. Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND [ Time Frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) ]
  3. Proportion of subjects in each arm who achieve HCV RNA < LOQ TND [ Time Frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24) ]
  4. Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs) [ Time Frame: Up to end of treatment (week 12) + 7 days ]
  5. Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort [ Time Frame: Up to end of treatment (week 12) + 7 days ]
  6. Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities [ Time Frame: Up to end of treatment (week 12) + 7 days ]
  7. Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b [ Time Frame: Post treatment 12 Week ]
  8. Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype) [ Time Frame: Post treatment 12 Week ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
  • Subjects with compensated cirrhosis
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.)
  • Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir (ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.

Exclusion Criteria:

  • Subjects without cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma(HCC)
  • 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01973049


  Show 49 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
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):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01973049     History of Changes
Other Study ID Numbers: AI443-113
2013-002458-66 ( EudraCT Number )
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 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
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents