Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients (HEPCAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01125189
First received: May 17, 2010
Last updated: September 23, 2015
Last verified: September 2015
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 Virus
Interventions: Drug: Daclatasvir
Drug: Placebo
Drug: peg-interferon 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
Participants were enrolled at 64 sites in 11 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 558 participants were enrolled in this study, and 395 participants were randomized and treated.

Reporting Groups
  Description
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Placebo + Peg-interferon Alfa-2a + Ribavirin Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.

Participant Flow for 2 periods

Period 1:   Treatment Period
    Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin     Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin     Placebo + Peg-interferon Alfa-2a + Ribavirin  
STARTED     159     158     78  
COMPLETED     128     123     37  
NOT COMPLETED     31     35     41  
Lack of Efficacy                 15                 18                 25  
Adverse Event                 7                 8                 8  
Withdrawal by Subject                 3                 1                 1  
Death                 1                 0                 0  
Lost to Follow-up                 1                 2                 1  
Poor compliance/noncompliance                 0                 1                 0  
Participants requested to discontinue                 1                 3                 4  
Other reasons                 1                 1                 0  
Completed 24 week treatment period only                 2                 1                 2  

Period 2:   Follow up Period
    Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin     Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin     Placebo + Peg-interferon Alfa-2a + Ribavirin  
STARTED     152 [1]   153 [1]   74 [1]
COMPLETED     132     138     58  
NOT COMPLETED     20     15     16  
Withdrawal by Subject                 3                 2                 5  
Death                 1                 0                 0  
Lost to Follow-up                 12                 9                 6  
Other reasons                 4                 4                 5  
[1] All participants who received treatment continued in the follow-up phase.



  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.
No text entered.

Reporting Groups
  Description
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Placebo + Peg-interferon Alfa-2a + Ribavirin Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin     Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin     Placebo + Peg-interferon Alfa-2a + Ribavirin     Total  
Number of Participants  
[units: participants]
  159     158     78     395  
Age, Customized  
[units: participants]
       
<65 years     154     154     77     385  
≥65 years     5     4     1     10  
Gender  
[units: participants]
       
Female     52     55     23     130  
Male     107     103     55     265  
Hepatitis C Virus RNA Distribution  
[units: participants]
       
<800,000 IU/mL     26     35     17     78  
≥800,000 IU/mL     133     123     61     317  
IL-28B Genotype  
[units: participants]
       
CC genotype     53     44     23     120  
CT genotype     82     86     38     206  
TT genotype     17     18     11     46  
Missing     7     10     6     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)   [ Time Frame: Weeks 4 and 12 ]

2.  Primary:   Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)   [ Time Frame: Follow-up Week 24 ]

3.  Primary:   Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died   [ Time Frame: From start of study treatment (day 1) up to follow-up Week 48 ]

4.  Secondary:   Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)   [ Time Frame: Week 4 ]

5.  Secondary:   Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)   [ Time Frame: Week 12 ]

6.  Secondary:   Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)   [ Time Frame: Follow-up Week 12 ]

7.  Secondary:   Percentage of Resistant Variants Associated With Virologic Failure   [ Time Frame: Follow-up Week 48 ]


  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: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
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: NCT01125189     History of Changes
Other Study ID Numbers: AI444-010
2010-018295-24 ( EudraCT Number )
Study First Received: May 17, 2010
Results First Received: August 13, 2015
Last Updated: September 23, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Canada: Health Canada
Canada: Regulatory Affairs Division Office of Clinical Trials Therapeutic Products Directorate
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Egypt: National Ethic Committee
Egypt: Ministry of Health, Drug Policy and Planning Center
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: The Swedish Data Inspection Board
Sweden: Central Ethics Board
United States: Food and Drug Administration