Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
1 other identifier
interventional
51
1 country
6
Brief Summary
The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care
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
Shorter than P25 for phase_2
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
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
October 12, 2015
CompletedOctober 12, 2015
September 1, 2015
9 months
November 19, 2009
August 17, 2015
September 23, 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, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
At Weeks 4 and 12 on treatment
Secondary Outcomes (4)
Percentage of Participants With Rapid Virologic Response (RVR)
At Week 4 on treatment
Percentage of Participants With Complete Early Virologic Response (cEVR)
At Week 12 on treatment
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
Follow-up Weeks 4, 12, and 24
Percentage of Participants With Virologic Failure
From on-treatment Week 1 to Follow-up Week 24
Other Outcomes (2)
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
From baseline to 30 days after last dose of study drug
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
From baseline to 30 days after last dose of study drug
Study Arms (5)
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
EXPERIMENTALTreatment Naive
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
EXPERIMENTALTreatment Naive
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
PLACEBO COMPARATORTreatment Naive
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
EXPERIMENTALNon-Responder
Arm E (BMS-790052, plus Peginterferon alfa-2b, 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
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Eligibility Criteria
You may qualify if:
- Patients chronically infected with hepatitis C virus (HCV) genotype 1
- HCV RNA viral load ≥10\*5\* IU/mL at screening
- Naïve or nonresponsive to the current standard of care
You may not qualify if:
- Cirrhosis
- Hepatocellular carcinoma
- Coinfection with hepatitis B virus, HIV-1 or HIV-2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Local Institution
Hiroshima, Hiroshima, 734-0037, Japan
Local Institution
Sapporo, Hokkaido, 060-0033, Japan
Local Institution
Kawasaki-Shi, Kanagawa, 2138587, Japan
Local Institution
Suita-Shi, Osaka, 5650871, Japan
Local Institution
Iruma-Gun, Saitama, 3500495, Japan
Local Institution
Minato-Ku, Tokyo, 105-0001, Japan
Related Publications (1)
Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.
PMID: 24468783DERIVED
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
September 1, 2010
Study Completion
September 1, 2010
Last Updated
October 12, 2015
Results First Posted
October 12, 2015
Record last verified: 2015-09