Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives) (Hallmark DUAL)
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| ClinicalTrials.gov Identifier: NCT01581203 |
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Recruitment Status :
Completed
First Posted : April 20, 2012
Last Update Posted : October 9, 2015
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| 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 |
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 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 |
| 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 |
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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 |
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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 |
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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 |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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
- 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 ]
- Proportion of subjects with anemia [ Time Frame: At 12 weeks post-treatment ]
- Proportion of subjects with rash [ Time Frame: At 12 weeks post-treatment ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases RNA Virus Infections 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 |