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

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ClinicalTrials.gov Identifier: NCT01017575
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Infection Drug: Daclatasvir Drug: Placebo Drug: Peginterferon alfa-2a Drug: Ribavirin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: From Week 4 up to Week 12 ]
    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 :
  1. Percentage of Participants With Rapid Virologic Response (RVR) [ Time Frame: Week 4 ]
    RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.

  2. Percentage of Participants With a Complete Early Virologic Response (cEVR) [ Time Frame: Week 12 ]
    cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.

  3. 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 ]
    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:
  1. 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 ]
    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.

  2. Number of Participants With Grade 3 to 4 Laboratory Abnormalities [ Time Frame: From screening up to Week 12 (treatment period) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017575


Locations
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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01017575    
Other Study ID Numbers: AI444-022
First Posted: November 20, 2009    Key Record Dates
Results First Posted: September 11, 2015
Last Update Posted: September 11, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Infections
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Blood-Borne Infections
 Communicable Diseases
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents