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

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ClinicalTrials.gov Identifier: NCT01016912
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C Infection
Interventions: Drug: BMS-790052
Drug: Placebo
Drug: Peginterferon alfa-2b
Drug: Ribavirin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 6 sites in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 51 participants were enrolled, of which 45 were randomized to receive treatment and 6 were discontinued for no longer meeting study criteria.

Reporting Groups
  Description
Placebo + pegIFNα + Ribavirin (Treatment-naive) Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive) Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive) Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders) Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders) Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.

Participant Flow for 2 periods

Period 1:   End of Treatment Period
    Placebo + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders)   Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)
STARTED   8   9   10   9   9 
Received Treatment   8   9   10   9   9 
COMPLETED   8   6   9   5   5 
NOT COMPLETED   0   3   1   4   4 
Lack of Efficacy                0                1                0                4                4 
Adverse Event                0                1                1                0                0 
Completed double-blind period only                0                1                0                0                0 

Period 2:   Follow-up Period
    Placebo + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders)   Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)
STARTED   8   9 [1]   10 [1]   9 [1]   9 [1] 
COMPLETED   8   9   9   8   9 
NOT COMPLETED   0   0   1   1   0 
Other reason                0                0                1                1                0 
[1] Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated participants who received at least 1 dose of study therapy.

Reporting Groups
  Description
Placebo + pegIFNα + Ribavirin (Treatment-naive) Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive) Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive) Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders) Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders) Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Total Total of all reporting groups

Baseline Measures
   Placebo + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)   Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)   Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)   Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   10   9   9   45 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.6  (8.78)   49.1  (15.09)   53.2  (9.96)   57.4  (6.11)   58.8  (9.46)   54.2  (10.46) 
Gender 
[Units: Participants]
           
Female   4   7   4   6   6   27 
Male   4   2   6   3   3   18 


  Outcome Measures

1.  Primary:   Percentage of Participants With Extended Rapid Virologic Response (eRVR)   [ Time Frame: At Weeks 4 and 12 on treatment ]

2.  Secondary:   Percentage of Participants With Rapid Virologic Response (RVR)   [ Time Frame: At Week 4 on treatment ]

3.  Secondary:   Percentage of Participants With Complete Early Virologic Response (cEVR)   [ Time Frame: At Week 12 on treatment ]

4.  Secondary:   Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24   [ Time Frame: Follow-up Weeks 4, 12, and 24 ]

5.  Secondary:   Percentage of Participants With Virologic Failure   [ Time Frame: From on-treatment Week 1 to Follow-up Week 24 ]

6.  Other Pre-specified:   Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome   [ Time Frame: From baseline to 30 days after last dose of study drug ]

7.  Other Pre-specified:   Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results   [ Time Frame: From baseline to 30 days after last dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BristolMyers Squibb Study Director
Organization: Bristol­Myers Squibb International Corporation
e-mail: clinical.trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01016912     History of Changes
Other Study ID Numbers: AI444-021
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: August 17, 2015
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015