Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A

Hemophilia A Clinical Trial

Official title:

Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362581
• Other study ID #: 3125055
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: February 9, 2015
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A
• Prophylaxis

Intervention

Other:
• prophylaxis treatment, on demand treatment

Locations

Country	Name	City	State
Thailand	pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital	Pratumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding episodes require treatment		one year	No
Primary	number of school days lost		one year	No
Primary	Number of admission days		one year	No
Secondary	Joint scores		one year	No
Secondary	Quality of life score		one year	No
Secondary	Amount of Facter VIII concentration used		one year	No