NCT02362581

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

January 29, 2015

Last Update Submit

February 9, 2015

Conditions

ProphylaxisHemophilia A

Keywords

Prophylaxis treatmentOn demand treatmentSevere hemophilia AModerate hemophilia A

Outcome Measures

Primary Outcomes (3)

  • Number of bleeding episodes require treatment

    one year

  • number of school days lost

    one year

  • Number of admission days

    one year

Secondary Outcomes (3)

  • Joint scores

    one year

  • Quality of life score

    one year

  • Amount of Facter VIII concentration used

    one year

Study Arms (1)

On demand treatment, prophylaxis treatment

EXPERIMENTAL

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

Interventions

prophylaxis treatment, on demand treatmentOTHER
Also known as: Hemofil M
On demand treatment, prophylaxis treatment

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 6 months to 18 years
  • Diagnosis severe and moderate hemophilia A

You may not qualify if:

  • platelet \< 100,000/mm3
  • No factor VIII inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital

Pratumwan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Darintr Sosothikul, Asso professer

    pediatric Hemato-Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Hematology/Oncology department

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 13, 2015

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

TH(1)