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
1 other identifier
interventional
55
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2009
CompletedFirst Posted
Study publicly available on registry
November 20, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
September 11, 2015
CompletedSeptember 11, 2015
August 1, 2015
1.8 years
November 19, 2009
August 13, 2015
August 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
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.
From Week 4 up to Week 12
Secondary Outcomes (3)
Percentage of Participants With Rapid Virologic Response (RVR)
Week 4
Percentage of Participants With a Complete Early Virologic Response (cEVR)
Week 12
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
Follow up Week 12, Follow up Week 24
Other Outcomes (2)
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
From Baseline up to 30 days after last dose of study drug
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
From screening up to Week 12 (treatment period)
Study Arms (5)
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
EXPERIMENTALTreatment Naive
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
EXPERIMENTALTreatment Naive
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
PLACEBO COMPARATORTreatment Naive
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
EXPERIMENTALNon-Responder
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
EXPERIMENTALNon-Responder
Interventions
Tablets, Oral, 10 mg, daily, 24-48 weeks
Tablets, Oral, 0 mg, daily, 48 weeks
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cirrhosis
- HCC
- Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Local Institution
Chiba, Chiba, Japan
Local Institution
Kurume-Shi, Fukuoka, 8300011, Japan
Local Institution
Okayama, Okayama-ken, 7008558, Japan
Local Institution
Osaka, Osaka, 5438555, Japan
Local Institution
Osaka, Osaka, 545-8586, Japan
Local Institution
Musashino-Shi, Tokyo, 180-0023, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BristolMyers Squibb Study Director
- Organization
- Bristol-Myers Squibb International Corporation
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2009
First Posted
November 20, 2009
Study Start
December 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
September 11, 2015
Results First Posted
September 11, 2015
Record last verified: 2015-08