Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
This study is currently recruiting participants.
Verified September 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01573351
First received: April 5, 2012
Last updated: February 7, 2013
Last verified: September 2012
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Purpose
The purpose of this study is to assess 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus |
Drug: Asunaprevir Drug: Daclatasvir Drug: Peg-interferon Alfa-2a Drug: Ribavirin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1 [ Time Frame: At 12 weeks post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment [ Time Frame: Through the end of treatment (maximum up to 24 weeks) plus 7 days ] [ Designated as safety issue: Yes ]
- Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene [ Time Frame: At post-treatment Week 12 ] [ Designated as safety issue: No ]
- Proportion of subjects with HCV RNA undetectable [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24 ] [ Designated as safety issue: No ]
- Proportion of subjects with HCV RNA < LOQ [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24) ] [ Designated as safety issue: No ]
- Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 390 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin |
Drug: Asunaprevir
Capsule, Oral, 100 mg, Twice daily, 24 weeks
Other Name: BMS-650032
Drug: Daclatasvir
Tablet, Oral, 60 mg, Once daily, 24 weeks
Other Name: BMS-790052
Drug: Peg-interferon Alfa-2a
Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablet, Oral, 1000 mg/1200 mg (depending on subject weight), Twice daily, 24 weeks
Other Name: Copegus®
|
Detailed Description:
- ASV = Asunaprevir (BMS-650032)
- DCV = Daclatasvir (BMS-790052)
- Peg = Peg-interferon Alfa-2a (PegIFN)
- Rib = Ribavirin (RBV)
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 1 or 4 who previously failed treatment with Peginterferon alfa-2a and ribavirin (P/R), classified as previous null and partial responders based on previous therapy
- 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
- Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
- Confirmed Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
- Confirmed Albumin < 3.5 g/dL (35 g/L)
- Alpha Fetoprotein (AFP) > 100 ng/mL or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
- Absolute neutrophil count (ANC) < 1.5 x 1000,000,000 cells/L (< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
- Confirmed Platelets < 90 x 1000,000,000 cells/L
- Hemoglobin < 12 g/dL for females or < 13 g/dL for males
- Any criteria that would exclude the subject from receiving P/R
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573351
Show 82 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 82 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: | NCT01573351 History of Changes |
| Other Study ID Numbers: | AI447-029, 2011-005422-21 |
| Study First Received: | April 5, 2012 |
| Last Updated: | February 7, 2013 |
| 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 Brazil: Ministry of Health 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 Switzerland: Swissmedic France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Mexico: Federal Commission for Sanitary Risks Protection Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: The Danish National Committee on Biomedical Research Ethics Sweden: Medical Products Agency Sweden: The National Board of Health and Welfare Sweden: Swedish Data Inspection Board Sweden: Swedish National Council on Medical Ethics Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency |
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