Back to resultsPhase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Primary Purpose
Hepatitis C Virus
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Daclatasvir
Daclatasvir
BMS-986094
BMS-986094
BMS-986094
Ribavirin
Placebo for BMS-986094
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus
Eligibility 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
Sites / Locations
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
Arm 2: Daclasasvir + BMS-986094 (200 mg)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Arm 5: Daclasasvir + BMS-986094 (200 mg)
Arm 6: Daclasasvir + BMS-986094 (200 mg)
Arm 7: Daclasasvir + BMS-986094 (200 mg)
Arm Description
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)
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)
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)
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)
Genotype 1 PI-failure subjects
Genotype 4 naive subjects
Genotype 2/3 NR/relapse Subjects
Outcomes
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)
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)
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)
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
Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)
Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01629732
Brief Title
Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
Arm Type
Experimental
Arm Description
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)
Arm Title
Arm 2: Daclasasvir + BMS-986094 (200 mg)
Arm Type
Experimental
Arm Description
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)
Arm Title
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Arm Type
Experimental
Arm Description
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)
Arm Title
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Arm Type
Experimental
Arm Description
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)
Arm Title
Arm 5: Daclasasvir + BMS-986094 (200 mg)
Arm Type
Experimental
Arm Description
Genotype 1 PI-failure subjects
Arm Title
Arm 6: Daclasasvir + BMS-986094 (200 mg)
Arm Type
Experimental
Arm Description
Genotype 4 naive subjects
Arm Title
Arm 7: Daclasasvir + BMS-986094 (200 mg)
Arm Type
Experimental
Arm Description
Genotype 2/3 NR/relapse Subjects
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052 (DCV)
Intervention Description
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052 (DCV)
Intervention Description
Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-986094
Intervention Description
Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-986094
Intervention Description
Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-986094
Intervention Description
Capsule, Oral, 200 mg, Once daily, 24 Weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®
Intervention Description
Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo for BMS-986094
Intervention Description
Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
Primary Outcome Measure Information:
Title
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)
Description
SVR = Sustained virologic response
HCV = Hepatitis C virus
RNA = Ribonucleic acid
LOQ = Limit of quantitation
Time Frame
Follow up Week 4
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
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