Back to resultsComparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
Primary Purpose
Prophylaxis, Hemophilia A
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
prophylaxis treatment, on demand treatment
Sponsored by
About this trial
This is an interventional treatment trial for Prophylaxis focused on measuring Prophylaxis treatment, On demand treatment, Severe hemophilia A, Moderate hemophilia A
Eligibility Criteria
Inclusion Criteria:
- Age between 6 months to 18 years
- Diagnosis severe and moderate hemophilia A
Exclusion Criteria:
- platelet < 100,000/mm3
- No factor VIII inhibitor
Sites / Locations
- pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
On demand treatment, prophylaxis treatment
Arm Description
On demand treatment arm:Patients received factorVIII concentrate(Hemofil M) when they had bleeding episodes. Prophylaxis arm: patients received factorVIII concentrate (Hemofil M) 30-35 unit/kg once a week
Outcomes
Primary Outcome Measures
Number of bleeding episodes require treatment
number of school days lost
Number of admission days
Secondary Outcome Measures
Joint scores
Quality of life score
Amount of Facter VIII concentration used
Full Information
NCT ID
NCT02362581
First Posted
January 29, 2015
Last Updated
February 9, 2015
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT02362581
Brief Title
Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
Official Title
Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of prophylaxis and on-demand treatment in children with moderate to severe hemophilia A.
This study determines to compare the efficacy of prophylaxis and on-demand treatment in moderate to severe hemophilia A children in King Chulalongkorn Memorial Hospital, Bangkok, Thailand
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis, Hemophilia A
Keywords
Prophylaxis treatment, On demand treatment, Severe hemophilia A, Moderate hemophilia A
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
On demand treatment, prophylaxis treatment
Arm Type
Experimental
Arm Description
On demand treatment arm:Patients received factorVIII concentrate(Hemofil M) when they had bleeding episodes.
Prophylaxis arm: patients received factorVIII concentrate (Hemofil M) 30-35 unit/kg once a week
Intervention Type
Other
Intervention Name(s)
prophylaxis treatment, on demand treatment
Other Intervention Name(s)
Hemofil M
Primary Outcome Measure Information:
Title
Number of bleeding episodes require treatment
Time Frame
one year
Title
number of school days lost
Time Frame
one year
Title
Number of admission days
Time Frame
one year
Secondary Outcome Measure Information:
Title
Joint scores
Time Frame
one year
Title
Quality of life score
Time Frame
one year
Title
Amount of Facter VIII concentration used
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 6 months to 18 years
Diagnosis severe and moderate hemophilia A
Exclusion Criteria:
platelet < 100,000/mm3
No factor VIII inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darintr Sosothikul, Asso professer
Organizational Affiliation
pediatric Hemato-Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital
City
Pratumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
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