Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-28

Study Completion Date

2015-12-17

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: DCV/ASV/BMS-791325+Sofosbuvir

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

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325

Intervention Type DRUG

Sofosbuvir

Intervention Type DRUG

Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir

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

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325

Intervention Type DRUG

Sofosbuvir

Intervention Type DRUG

Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a

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

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Peginterferon α-2a

Intervention Type DRUG

Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a

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

Group Type OTHER

Ribavirin

Intervention Type DRUG

Sofosbuvir

Intervention Type DRUG

Peginterferon α-2a

Intervention Type DRUG

Interventions

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DCV/ASV/BMS-791325

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Sofosbuvir

Intervention Type DRUG

Peginterferon α-2a

Intervention Type DRUG

Other Intervention Names

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Sovaldi®

Eligibility Criteria

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Inclusion Criteria

* Males and Females ≥18 years of age, inclusive
* Chronic HCV infection Genotype 1 only
* Non-cirrhotic
* Treatment naive subjects with no previous exposure to an Interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease, polymerase inhibitor, etc.)

Exclusion Criteria

* HCV Genotype other than Genotype 1
* Documented or suspected hepatocellular carcinoma
* Evidence of decompensated liver disease
* Contraindication(s) to Peg/RBV therapy

Eligible Sex

ALL

Accepts Healthy Volunteers

No