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Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00874770
First received: April 2, 2009
Last updated: September 23, 2015
Last verified: September 2015
Results First Received: August 6, 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 alpha-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 14 sites in France and USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 74 participants were enrolled, of which 48 were randomized to receive treatment and 26 were not randomized: 22 no longer met study criteria, 2 withdrew consent, 1 was lost to follow-up, and 1 due to other reasons.

Reporting Groups
  Description
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Placebo+pegIFNα-2a+Ribavirin Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).

Participant Flow:   Overall Study
    Daclatasvir 3 mg + pegIFNα-2a + Ribavirin     Daclatasvir 10 mg + pegIFNα-2a + Ribavirin     Daclatasvir 60 mg + pegIFNα-2a + Ribavirin     Placebo+pegIFNα-2a+Ribavirin  
STARTED     12     12     12     12  
COMPLETED     7     11     8     7  
NOT COMPLETED     5     1     4     5  
Lack of Efficacy                 2                 0                 0                 2  
Adverse Event                 1                 1                 4                 2  
Lost to Follow-up                 1                 0                 0                 1  
Subject no Longer Meets Study Criteria                 1                 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.
The analysis was performed in the treated population defined as all participants who received at least 1 dose of study therapy.

Reporting Groups
  Description
Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Placebo+pegIFNα-2a+Ribavirin Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
Total Total of all reporting groups

Baseline Measures
    Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin     Daclatasvir 10-mg+pegIFNα-2a+Ribavirin     Daclatasvir 60-mg+pegIFNα-2a+Ribavirin     Placebo+pegIFNα-2a+Ribavirin     Total  
Number of Participants  
[units: participants]
  12     12     12     12     48  
Age  
[units: years]
Mean (Standard Deviation)
  52  (8.56)     53.2  (9.11)     52  (7.34)     48  (10.20)     51.3  (8.80)  
Gender  
[units: participants]
         
Female     3     4     5     4     16  
Male     9     8     7     8     32  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12   [ Time Frame: A Weeks 4 and 12 ]

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

3.  Secondary:   Percentage of Participants With Early Virologic Response (EVR) at Week 12   [ Time Frame: At Week 12 ]

4.  Secondary:   Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12   [ Time Frame: At Week 12 ]

5.  Other Pre-specified:   Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase   [ Time Frame: SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug ]

6.  Other Pre-specified:   Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period   [ Time Frame: From Day 31 up to Week 24 of post treatment follow-up ]

7.  Other Pre-specified:   Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results   [ Time Frame: From screening up to Week 12 (treatment period) ]


  Serious Adverse Events


  Other Adverse Events


  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: Bristol-Myers 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: NCT00874770     History of Changes
Other Study ID Numbers: AI444-014
EUDRACT# 2009-010149-29
Study First Received: April 2, 2009
Results First Received: August 6, 2015
Last Updated: September 23, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
France: Ministry of Health