Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
NCT ID: NCT01629732
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-03-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
BMS-986094
Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
Placebo for BMS-986094
Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
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)
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
BMS-986094
Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
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)
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
BMS-986094
Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
Ribavirin
Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
Placebo for BMS-986094
Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
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)
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
BMS-986094
Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
Ribavirin
Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
Arm 5: Daclasasvir + BMS-986094 (200 mg)
Genotype 1 PI-failure subjects
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
BMS-986094
Capsule, Oral, 200 mg, Once daily, 24 Weeks
Arm 6: Daclasasvir + BMS-986094 (200 mg)
Genotype 4 naive subjects
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
BMS-986094
Capsule, Oral, 200 mg, Once daily, 24 Weeks
Arm 7: Daclasasvir + BMS-986094 (200 mg)
Genotype 2/3 NR/relapse Subjects
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
BMS-986094
Capsule, Oral, 200 mg, Once daily, 24 Weeks
Interventions
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Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
BMS-986094
Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
BMS-986094
Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
BMS-986094
Capsule, Oral, 200 mg, Once daily, 24 Weeks
Ribavirin
Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
Placebo for BMS-986094
Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 medical condition contributing to chronic liver disease other than HCV
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Orlando, Florida, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2012-002519-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI472-007
Identifier Type: -
Identifier Source: org_study_id
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