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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
History of Changes
Results First Received: August 13, 2015  
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
Condition: Hepatitis C Infection
Interventions: Drug: Daclatasvir
Drug: Placebo
Drug: Peginterferon alfa-2a
Drug: Ribavirin

  Participant Flow
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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 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node.

Reporting Groups
  Description
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.

Participant Flow:   Overall Study
    Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)     Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)     Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)     Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)     Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)  
STARTED     8     9     8     8     9  
COMPLETED     7     7     8     7     6  
NOT COMPLETED     1     2     0     1     3  
Lack of Efficacy                 0                 1                 0                 1                 1  
Adverse Event                 0                 1                 0                 0                 2  
Withdrawal by Subject                 1                 0                 0                 0                 0  



  Baseline Characteristics
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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-2a+Ribavirin (Treatment Naive) Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Total Total of all reporting groups

Baseline Measures
    Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)     Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)     Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)     Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)     Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)     Total  
Number of Participants  
[units: participants]
 		  8     9     8     8     9     42  
Age, Customized  
[units: participants]
 		           
<65 years     7     8     6     6     8     35  
>=65 years     1     1     2     2     1     7  
Gender  
[units: participants]
 		           
Female     5     5     6     2     4     22  
Male     3     4     2     6     5     20  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Extended Rapid Virologic Response (eRVR)   [ Time Frame: From Week 4 up to Week 12 ]
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2.  Secondary:   Percentage of Participants With Rapid Virologic Response (RVR)   [ Time Frame: Week 4 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With a Complete Early Virologic Response (cEVR)   [ Time Frame: Week 12 ]
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4.  Secondary:   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 ]
  Show Outcome Measure 4

5.  Other Pre-specified:   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 ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Number of Participants With Grade 3 to 4 Laboratory Abnormalities   [ Time Frame: From screening up to Week 12 (treatment period) ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  More Information
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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



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