Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
This study is currently recruiting participants.
Verified December 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01581203
First received: April 18, 2012
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus |
Drug: Asunaprevir (ASV) Drug: Daclatasvir (DCV) Drug: PBO matching ASV Drug: Placebo (PBO) matching DCV Drug: Pegylated-interferon alfa 2a (PegIFN) Drug: Ribavirin (RBV) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Proportion of subjects with anemia [ Time Frame: At 12 weeks post-treatment ] [ Designated as safety issue: No ]
- Proportion of subjects with rash [ Time Frame: At 12 weeks post-treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 725 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1: Null or Partial Responder to P/R (ASV + DCV)
Subjects meeting prespecified rescue criteria in the null or partial responder cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)
|
Drug: Asunaprevir (ASV)
Capsule, Oral, 100 mg, Twice daily, 24 Weeks
Other Name: BMS-650032 (ASV)
Drug: Daclatasvir (DCV)
Tablet, Oral, 60 mg, Once daily, 24 Weeks
Other Name: BMS-790052 (DCV)
Drug: Pegylated-interferon alfa 2a (PegIFN)
Injection, subcutaneously (SC), 180 mcg/0.5 mL, once weekly, 24 weeks
Other Name: Pegasys
Drug: Ribavirin (RBV)
Tablet, Oral, 1000 mg / 1200 mg (depending on subject weight), twice daily, 24 weeks
Other Name: Copegus
|
| Experimental: Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) |
Drug: Asunaprevir (ASV)
Capsule, Oral, 100 mg, Twice daily, 24 Weeks
Other Name: BMS-650032 (ASV)
Drug: Daclatasvir (DCV)
Tablet, Oral, 60 mg, Once daily, 24 Weeks
Other Name: BMS-790052 (DCV)
|
|
Experimental: Arm 3: Treatment naive (ASV + DCV / Matching PBO)
[Subjects will receive ASV + DCV for 24 weeks] or [placebo (PBO) matching ASV + PBO matching DCV for 12 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) |
Drug: Asunaprevir (ASV)
Capsule, Oral, 100 mg, Twice daily, 24 Weeks
Other Name: BMS-650032 (ASV)
Drug: Daclatasvir (DCV)
Tablet, Oral, 60 mg, Once daily, 24 Weeks
Other Name: BMS-790052 (DCV)
Drug: PBO matching ASV
Capsule, Oral, 0 mg, Twice daily, 12 Weeks
Drug: Placebo (PBO) matching DCV
Tablet, Oral, 0 mg, Once daily, 12 Weeks
Drug: Pegylated-interferon alfa 2a (PegIFN)
Injection, subcutaneously (SC), 180 mcg/0.5 mL, once weekly, 24 weeks
Other Name: Pegasys
Drug: Ribavirin (RBV)
Tablet, Oral, 1000 mg / 1200 mg (depending on subject weight), twice daily, 24 weeks
Other Name: Copegus
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581203
Show 128 Study Locations
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Show 128 Study LocationsSponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01581203 History of Changes |
| Other Study ID Numbers: | AI447-028, 2011-005446-35 |
| Study First Received: | April 18, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration Korea: Food and Drug Administration Taiwan: Department of Health Taiwan: National Bureau of Controlled Drugs Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Canada: Health Canada Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application Germany: Federal Institute for Drugs and Medical Devices Germany: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) New Zealand: Medsafe Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Ireland: Irish Medicines Board United Kingdom: Medicines and Healthcare Products Regulatory Agency Israel: Israeli Health Ministry Pharmaceutical Administration Poland: National Institute of Medicines Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Brazil: National Health Surveillance Agency Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Interferons Ribavirin |
Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013