Clinical trial NCT00874770: Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
Official title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Infection
Keywords: Antivirals
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.


Eligibility criteria: Key Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1
* HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening
* Treatment naive

Key Exclusion Criteria:

* Women of child-bearing potential
* Cirrhosis
* Coinfection with HIV or hepatitis B virus

Primary outcomes:
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
timeFrame: A Weeks 4 and 12
Secondary outcomes:
measure: Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
timeFrame: At Week 4
measure: Percentage of Participants With Early Virologic Response (EVR) at Week 12
timeFrame: At Week 12
measure: Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
timeFrame: At Week 12
Other outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
timeFrame: SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
timeFrame: From Day 31 up to Week 24 of post treatment follow-up
measure: Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
timeFrame: From screening up to Week 12 (treatment period)
Locations:
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists (Alds)
state: Alabama
city: Aurora
country: United States
facility: University Of Colorado Denver & Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Springfield
country: United States
facility: Llc Dba The Research Institute
state: Massachusetts
city: Bronx
country: United States
facility: Veterans Affairs Medical Center
state: New York
city: Statesville
country: United States
facility: Carolinas Center For Liver Disease
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Arlington
country: United States
facility: North Texas Research Institute
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Creteil
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hezode C, Lim JK, Bronowicki JP, Abrams GA, Brau N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.