A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01079806
First received: March 2, 2010
Last updated: September 25, 2014
Last verified: September 2014
Results First Received: March 17, 2014  
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: Chronic Hepatitis B Virus, Pediatric
Interventions: Drug: Entecavir
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 228 patients enrolled, 43 no longer met study criteria, 4 withdrew consent, and 1 withdrew for surgery. While the primary endpoint analysis was based on a randomized sample size of 123 participants, the overall study population was augmented to 180 to meet global regulatory requirements. All 180 randomized patients received study drug.

Reporting Groups
  Description
Entecavir Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
Placebo Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response

Participant Flow for 2 periods

Period 1:   Day 1 to Week 96
    Entecavir     Placebo  
STARTED     120 [1]   60 [1]
Received Treatment     120     60  
Primary Endpoint Cohort     82     41  
COMPLETED     116 [2]   56 [3]
NOT COMPLETED     4     4  
Adverse Event                 0                 2  
Withdrawal by Subject                 3                 1  
Pregnancy                 0                 1  
Poor compliance or noncompliance                 1                 0  
[1] Randomized
[2] Includes 91 continuing treatment
[3] Includes 53 continuing treatment

Period 2:   Long-term Follow-up: Day 1-End of Study
    Entecavir     Placebo  
STARTED     14     6  
COMPLETED     14     4  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  



  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 participants who received study drug

Reporting Groups
  Description
Entecavir Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
Placebo Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
Total Total of all reporting groups

Baseline Measures
    Entecavir     Placebo     Total  
Number of Participants  
[units: participants]
  120     60     180  
Age  
[units: Years]
Mean ± Standard Deviation
  10.5  ± 4.87     10.8  ± 4.82     10.6  ± 4.84  
Age, Customized  
[units: Participants]
     
>=2 years to <=6 years     27     14     41  
>6 years to <=12 years     31     15     46  
>12 years to <18 years     62     31     93  
Gender  
[units: Participants]
     
Female     42     29     71  
Male     78     31     109  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     2     0     2  
Not Hispanic or Latino     48     21     69  
Unknown or Not Reported     70     39     109  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     57     30     87  
Black/African American     14     2     16  
Native Hawaiian/Other Pacific Islander     1     0     1  
White     44     27     71  
Other     4     1     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48   [ Time Frame: At Week 48 ]

2.  Secondary:   Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48   [ Time Frame: At Week 48 ]

3.  Secondary:   Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48   [ Time Frame: At Week 48 ]

4.  Secondary:   Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48   [ Time Frame: At Week 48 ]

5.  Secondary:   Percentage of Participants With Hepatitis B e (HBe) Seroconversion at Week 48   [ Time Frame: At Week 48 ]

6.  Secondary:   Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression   [ Time Frame: Day 1 through Week 48 on blinded therapy ]

7.  Secondary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4)   [ Time Frame: Day 1 through Week 48 on blinded therapy ]

8.  Secondary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued)   [ Time Frame: Day 1 through Week 48 on blinded therapy ]


  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


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01079806     History of Changes
Other Study ID Numbers: AI463-189 ST
Study First Received: March 2, 2010
Results First Received: March 17, 2014
Last Updated: September 25, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: ANVIA, CONEP
Canada: Health Canada
Greece: Ethics Committee
Greece: National Organization of Medicines
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut
India: Central Drugs Standard Control Organization
India: Indian Council of Medical Research
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Korea: Food and Drug Administration
Poland: National Institute of Medicines
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