Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

Detailed description:
Allocation:

Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance

Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice

Number of Arms:

Initial Therapy: 2 Groups

Rescue Therapy: 2 Groups

Arms:
arm 1: Initial Therapy:

Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 4 weeks

Sofosbuvir 400 mg tablet once daily orally for 4 weeks arm 2: Initial Therapy

Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 6 weeks

Sofosbuvir 400 mg tablet once daily orally for 6 weeks arm 3: Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 12 weeks

Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks

With or without Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks arm 4: Sofosbuvir 400 mg tablet once daily orally for 12 weeks

Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks

Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks

Interventions: intervention 1: DCV/ASV/BMS-791325 intervention 2: Ribavirin intervention 3: Sofosbuvir intervention 4: Peginterferon α-2a
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: