Clinical trial NCT02175966: Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
Official title: Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 (SVR12)
timeFrame: 12 Weeks after treatment discontinuation (Follow-up Week 12)
measure: Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
timeFrame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
measure: Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
timeFrame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Secondary outcomes:
measure: Percentage of Participants With End of Treatment Response (EOTR)
timeFrame: End of the treatment
measure: Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND
timeFrame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)
measure: Percentage of Participants Who Achieved HCV RNA < LLOQ TND
timeFrame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24
measure: Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b
timeFrame: Post-treatment Week 12
measure: Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)
timeFrame: Post-treatment Week 12
Other outcomes:
Locations:
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School Of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health - University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Med Center
state: Indiana
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sulkowski MS, Flamm S, Kayali Z, Lawitz EJ, Kwo P, McPhee F, Torbeyns A, Hughes EA, Swenson ES, Yin PD, Linaberry M. Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study). Liver Int. 2017 Jun;37(6):836-842. doi: 10.1111/liv.13335. Epub 2017 Feb 2.