Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01455090 | Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications | PHASE2 | COMPLETED | 320 | — | — | Nov 30, 2011 | Jul 31, 2015 | Apr 27, 2017 | 32 | United States, France +1 |
| NCT00722358 | A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects | PHASE2 | COMPLETED | 15 | — | — | Dec 1, 2008 | Dec 1, 2009 | Jun 27, 2011 | 5 | United States, Puerto Rico |
| Arm | Type | Description |
|---|---|---|
| Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg) | EXPERIMENTAL | BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks |
| Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg) | EXPERIMENTAL | BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks |
| Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks |
| Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks |
| Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBV | EXPERIMENTAL | \* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablets orally twice daily 12 weeks BMS-790052 30 mg tablets orally twice daily 12 weeks BMS-791325 75 mg tablets orally twice daily 12 weeks Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks \[if subject is \< 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM\] |
| BMS-650032 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BMS-650032 | DRUG | - |
| BMS-790052 | DRUG | - |
| BMS-791325 | DRUG | - |
| Ribavirin | DRUG | - |
| Placebo | DRUG | Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo |
Inclusion Criteria: * Men and women, ages ≥18 years of age * Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylate...