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Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00874770
First received: April 2, 2009
Last updated: September 23, 2015
Last verified: September 2015

April 2, 2009
September 23, 2015
June 2009
November 2009   (final data collection date for primary outcome measure)
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 [ Time Frame: A Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00874770 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
  • Percentage of Participants With Early Virologic Response (EVR) at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.
  • Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12
Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities and, [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
  • 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 [ Time Frame: From Day 31 up to Week 24 of post treatment follow-up ] [ Designated as safety issue: Yes ]
    An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
  • Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results [ Time Frame: From screening up to Week 12 (treatment period) ] [ Designated as safety issue: Yes ]
    Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.
Not Provided
 
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C Infection
  • Drug: Daclatasvir
    Tablets, oral, 3 mg, Daily, 48 weeks
  • Drug: Daclatasvir
    Tablets, oral, 10 mg, Daily, 48 weeks
  • Drug: Daclatasvir
    Tablets, oral, 60 mg, Daily, 48 weeks
  • Drug: Placebo
    Tablet, oral, 0 mg, Daily 48 weeks
  • Drug: Peginterferon alpha-2a
    Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
    Other Name: Pegasys
  • Drug: ribavirin
    Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
    Other Name: Copegus
  • Experimental: Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
    Active Comparator
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
    Active Comparator
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
    Active Comparator
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D)
    Interventions:
    • Drug: Placebo
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hézode C, Lim JK, Bronowicki JP, Abrams GA, Bräu 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
January 2011
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
Argentina
 
NCT00874770
AI444-014, EUDRACT# 2009-010149-29
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP