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Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives) (Hallmark DUAL)

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ClinicalTrials.gov Identifier: NCT01581203
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: Asunaprevir (ASV) Drug: Daclatasvir (DCV) Drug: Pegylated-interferon alfa 2a (PegIFN) Drug: Ribavirin (RBV) Phase 3

Detailed Description:

Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study)

Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open

Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Study Start Date : May 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Null or Partial Responder to P/R (ASV + DCV)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks

 Drug: Asunaprevir (ASV)
Other Name: BMS-650032

Drug: Daclatasvir (DCV)
Other Name: BMS-790052
Experimental: Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks

 Drug: Asunaprevir (ASV)
Other Name: BMS-650032

Drug: Daclatasvir (DCV)
Other Name: BMS-790052
Experimental: Arm 3: Treatment naive (ASV + DCV)

[Subjects will receive ASV + DCV for 24 weeks] followed by ASV + DCV for 24 weeks in protocol AI444026]

Subjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks

Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks

Ribavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks

 Drug: Asunaprevir (ASV)
Other Name: BMS-650032

Drug: Daclatasvir (DCV)
Other Name: BMS-790052

Drug: Pegylated-interferon alfa 2a (PegIFN)
Other Name: Pegasys

Drug: Ribavirin (RBV)
Other Name: Copegus
Experimental: Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week

Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks

Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks

Ribavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks

 Drug: Asunaprevir (ASV)
Other Name: BMS-650032

Drug: Daclatasvir (DCV)
Other Name: BMS-790052

Drug: Pegylated-interferon alfa 2a (PegIFN)
Other Name: Pegasys

Drug: Ribavirin (RBV)
Other Name: Copegus


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive [ Time Frame: At 12 weeks post-treatment ]

Secondary Outcome Measures :
  1. Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R [ Time Frame: Post-treatment Week 12 ]
  2. On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) [ Time Frame: End of Treatment (up to 48 weeks) plus 7 days ]
  3. Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects [ Time Frame: Up to first 12 weeks ]
  4. Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort [ Time Frame: Post-treatment Week 12 ]
  5. Proportion of genotype 1b subjects with HCV RNA undetectable [ Time Frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort ]
    eRVR = Extended rapid virologic response, EOT = End of treatment

  6. Proportion of genotypes 1b subjects with HCV RNA < LOQ [ Time Frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort ]
  7. Proportion of subjects with anemia [ Time Frame: At 12 weeks post-treatment ]
  8. Proportion of subjects with rash [ Time Frame: At 12 weeks post-treatment ]

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:

  • Males and females, ≥ 18 years of age
  • HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
  • HCV RNA ≥ 10,000 IU/mL
  • Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
  • Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Exclusion Criteria:

  • Prior treatment of HCV with HCV direct acting antiviral (DAA)
  • Evidence of a medical condition contributing to chronic liver disease other than HCV
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
  • Diagnosed or suspected hepatocellular carcinoma or other malignancies
  • Uncontrolled diabetes or hypertension
Contacts and Locations
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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): NCT01581203


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: NCT01581203    
Other Study ID Numbers: AI447-028
2011-005446-35 ( EudraCT Number )
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Interferons
Ribavirin
 Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Asunaprevir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors