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



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/24/2017
Start Date:July 2014
End Date:December 2015

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

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.

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

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

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
We found this trial at
5
sites
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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1101 East 33rd Street
Lutherville, Maryland 21093
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Rialto, California 92377
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San Antonio, Texas 78215
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