Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C - Full Text View

Purpose

The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin

Condition	Intervention	Phase
Hepatitis C Virus	Drug: Daclatasvir Drug: BMS-986094 Drug: Ribavirin Drug: Placebo for BMS-986094	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a) [ Time Frame: Follow up Week 4 ] [ Designated as safety issue: No ]
- SVR = Sustained virologic response
- HCV = Hepatitis C virus
- RNA = Ribonucleic acid
- LOQ = Limit of quantitation

Secondary Outcome Measures:

Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b) [ Time Frame: Follow up Week 4 (SVR4) ] [ Designated as safety issue: No ]
Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7) [ Time Frame: Follow up Week 4 (SVR4) ] [ Designated as safety issue: No ]
Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment [ Time Frame: Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms) ] [ Designated as safety issue: No ]
Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable) [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24) ] [ Designated as safety issue: No ]
Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24) ] [ Designated as safety issue: No ]
Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities [ Time Frame: Up to post treatment Week 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	360
Study Start Date:	September 2012
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)	Drug: Daclatasvir Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks Other Name: BMS-790052 (DCV) Drug: BMS-986094 Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks Drug: Placebo for BMS-986094 Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
Experimental: Arm 2: Daclasasvir + BMS-986094 (200 mg) Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment)	Drug: Daclatasvir Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks Other Name: BMS-790052 (DCV) Drug: BMS-986094 Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
Experimental: Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)	Drug: Daclatasvir Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks Other Name: BMS-790052 (DCV) Drug: BMS-986094 Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks Drug: Ribavirin Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks Other Name: Copegus® Drug: Placebo for BMS-986094 Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
Experimental: Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)	Drug: Daclatasvir Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks Other Name: BMS-790052 (DCV) Drug: BMS-986094 Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks Drug: Ribavirin Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks Other Name: Copegus®
Experimental: Arm 5: Daclasasvir + BMS-986094 (200 mg) Genotype 1 PI-failure subjects	Drug: Daclatasvir Film coated tablet, Oral, 60 mg, Once daily, 24 weeks Other Name: BMS-790052 (DCV) Drug: BMS-986094 Capsule, Oral, 200 mg, Once daily, 24 Weeks
Experimental: Arm 6: Daclasasvir + BMS-986094 (200 mg) Genotype 4 naive subjects	Drug: Daclatasvir Film coated tablet, Oral, 60 mg, Once daily, 24 weeks Other Name: BMS-790052 (DCV) Drug: BMS-986094 Capsule, Oral, 200 mg, Once daily, 24 Weeks
Experimental: Arm 7: Daclasasvir + BMS-986094 (200 mg) Genotype 2/3 NR/relapse Subjects	Drug: Daclatasvir Film coated tablet, Oral, 60 mg, Once daily, 24 weeks Other Name: BMS-790052 (DCV) Drug: BMS-986094 Capsule, Oral, 200 mg, Once daily, 24 Weeks

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
Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4
HCV RNA viral load ≥ 10,000 IU/mL
Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
Body Mass Index (BMI) of 18 to 35 kg/m2
Seronegative for Hepatitis C virus (HIV) and Hepatitis B

Exclusion Criteria:

Evidence of decompensated liver disease
Evidence of medical condition contributing to chronic liver disease other than HCV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629732

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01629732 History of Changes
Other Study ID Numbers:	AI472-007, 2012-002519-24
Study First Received:	June 26, 2012
Last Updated:	August 6, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Germany: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council New Zealand: Medsafe

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections

Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013