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
  Purpose
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

Condition Intervention Phase
Hepatitis C Infection
Drug: Daclatasvir
Drug: Placebo
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 55
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 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 B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 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®
Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
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 D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
Drug: Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 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 E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
Drug: Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 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®

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017575

Locations
Japan
Local Institution
Chiba-Shi, Chiba, Japan
Local Institution
Kurume-Shi, Fukuoka, Japan, 8300011
Local Institution
Okayama-Shi, Okayama, Japan, 7008558
Local Institution
Osaka-Shi, Osaka, Japan, 5438555
Local Institution
Osaka-Shi, Osaka, Japan, 545-8586
Local Institution
Musashino-Shi, Tokyo, Japan, 180-0023
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01017575     History of Changes
Other Study ID Numbers: AI444-022 
Study First Received: November 19, 2009
Results First Received: August 13, 2015
Last Updated: August 13, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016