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

February 9, 2015 updated by: Darintr Sosothikul, Chulalongkorn University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Pratumwan, Bangkok, Thailand, 10330
        • pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: On demand treatment, prophylaxis treatment

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
Other: prophylaxis treatment, on demand treatment
Other Names:
  • Hemofil M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of bleeding episodes require treatment
Time Frame: one year
one year
number of school days lost
Time Frame: one year
one year
Number of admission days
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Joint scores
Time Frame: one year
one year
Quality of life score
Time Frame: one year
one year
Amount of Facter VIII concentration used
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Darintr Sosothikul, Asso professer, pediatric Hemato-Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3125055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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