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

NCT ID: NCT02362581

Last Updated: 2015-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Prophylaxis Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

prophylaxis treatment, on demand treatment

Intervention Type OTHER

Interventions

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prophylaxis treatment, on demand treatment

Intervention Type OTHER

Other Intervention Names

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Hemofil M

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Darintr Sosothikul

Pediatric Hematology/Oncology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darintr Sosothikul, Asso professer

Role: PRINCIPAL_INVESTIGATOR

pediatric Hemato-Oncology

Locations

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pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital

Pratumwan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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3125055

Identifier Type: -

Identifier Source: org_study_id

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