Comparison of Prophylaxis and On-demand Treatment in Chil... | NCT02362581

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

NCT02362581

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Feb 13, 2015Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Prophylaxis
Hemophilia A

Interventions

prophylaxis treatment, on demand treatment

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jan 29, 2015

First Submission Date that Met QC Criteria

Feb 9, 2015

First Posted Date

Feb 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2015

Last Update Posted Date

Feb 13, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Darintr Sosothikul, Pediatric Hematology/Oncology department, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
prophylaxis treatment, on demand treatment	Other		On demand treatment, prophylaxis treatment	Hemofil M

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darintr Sosothikul, Asso professer	pediatric Hemato-Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital		Pratumwan	Bangkok	10330	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C078147	F8 protein, human

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided