Clinical trial NCT01448044: Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
Official title: A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: hepatitis C virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).


Eligibility criteria: Inclusion Criteria:

* Participants chronically infected with HCV Genotype 4
* HCV RNA viral load of ≥ 10,000 IU/mL
* No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
* Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted

Exclusion Criteria:

* Evidence of decompensated liver disease
* Documented or suspected Hepatocellular carcinoma (HCC)
* Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening

Primary outcomes:
measure: Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
timeFrame: Week 12 (Follow-up period)
Secondary outcomes:
measure: Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
timeFrame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48
measure: Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
timeFrame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48
measure: Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
timeFrame: Post Treatment Weeks 12, 24
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
timeFrame: From Day 1 (start of study treatment) up to Follow-up Week 4
Other outcomes:
Locations:
city: San Clemente
country: United States
facility: Scti Research Foundation
state: California
city: Worcester
country: United States
facility: Umass Memorial Medical Center
state: Massachusetts
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Annandale
country: United States
facility: Metropolitan Research
state: Virginia
city: Bondy Cedex
country: France
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: La Roche-Sur-Yon Cedex 9
country: France
facility: Local Institution
city: Marseille Cedex 08
country: France
facility: Local Institution
city: Nice Cedex 03
country: France
facility: Local Institution
city: Orleans Cedex 2
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Toulouse Cedex 09
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Thesaloniki
country: Greece
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.