Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01017575
First received: November 19, 2009
Last updated: August 13, 2015
Last verified: August 2015

November 19, 2009
August 13, 2015
December 2009
October 2011   (final data collection date for primary outcome measure)
Percentage of Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: From Week 4 up to Week 12 ] [ Designated as safety issue: Yes ]
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
  • Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
  • Antiviral activity, as determined by the proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL [ Time Frame: at both Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01017575 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Rapid Virologic Response (RVR) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.
  • Percentage of Participants With a Complete Early Virologic Response (cEVR) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.
  • Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 [ Time Frame: Follow up Week 12, Follow up Week 24 ] [ Designated as safety issue: No ]
    SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.
  • Proportion of subjects with rapid virologic response (RVR), defined as HCV RNA < 15 IU/mL [ Time Frame: at Week 4 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with early virologic response (EVR), defined as ≥ 2 log10 decrease in HCV RNA from baseline [ Time Frame: at Week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA < 15 IU/mL at follow-up (SVR12) and (SVR24), respectively [ Time Frame: Week 12 (SVR12) and Week 24 (SVR24), respectively ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with clinical failure [ Time Frame: Weeks 4, 12, post-treatment Week 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. [ Time Frame: From Baseline up to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with 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.
  • Number of Participants With Grade 3 to 4 Laboratory Abnormalities [ 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: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (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; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.
Not Provided
 
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
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, 10 mg, daily, 24-48 weeks
  • Drug: Daclatasvir
    Tablets, Oral, 60 mg, daily, 24-48 weeks
  • Drug: Placebo
    Tablets, Oral, 0 mg, daily, 48 weeks
  • Drug: Peginterferon alfa-2a
    Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
    Other Name: Pegasys®
  • Drug: Ribavirin
    Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
    Other Name: Copegus®
  • Experimental: Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
    Treatment Naive
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
    Treatment Naive
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
    Treatment Naive
    Interventions:
    • Drug: Placebo
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
    Non-Responder
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
    Non-Responder
    Interventions:
    • Drug: Daclatasvir
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
October 2011
October 2011   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Subjects chronically infected with hepatitis C virus (HCV) genotype 1
  • HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
  • The current standard of care naïve or non-responder

Key Exclusion Criteria:

  • Cirrhosis
  • HCC
  • Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Both
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01017575
AI444-022
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2015

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