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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01629732
First received: June 26, 2012
Last updated: May 8, 2014
Last verified: May 2014
  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:


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 ]

Enrollment: 0
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Local Institution
Orlando, Florida, United States, 32804
Sponsors 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: NCT01629732     History of Changes
Other Study ID Numbers: AI472-007, 2012-002519-24
Study First Received: June 26, 2012
Last Updated: May 8, 2014
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 C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014