ProphylaxisNCT02362581
Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
A study testing prophylaxis treatment, on demand treatment in people with Prophylaxis and Hemophilia A, run by Chulalongkorn University at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Prophylaxis, Hemophilia A
- What is being tested?
- prophylaxis treatment, on demand treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 6 months to 18 years
- Diagnosis severe and moderate hemophilia A
Who cannot join
- platelet < 100,000/mm3
- No factor VIII inhibitor
Trial locations and contacts
1 site in 1 country.
Thailand1 site
pediatric Hemato-oncology department, King Chulalongkorn Memorial Hospital
Pratumwan, Bangkok, 10330
About this study
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
- Conditions
- Prophylaxis, Hemophilia A
- Being tested
- prophylaxis treatment, on demand treatment
- Keywords
- Prophylaxis treatment, On demand treatment, Severe hemophilia A, Moderate hemophilia A
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylaxis treatment, on demand treatmentOther
Also called Hemofil M
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: prophylaxis treatment, on demand treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding episodes require treatment
Measured: one year
number of school days lost
Measured: one year
Number of admission days
Measured: one year
Secondary outcomes (3)
Joint scores
Measured: one year
Quality of life score
Measured: one year
Amount of Facter VIII concentration used
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProphylaxisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darintr Sosothikul, Chulalongkorn University
- Investigators
- Darintr Sosothikul, Asso professer, Principal investigator, pediatric Hemato-Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362581
- Sponsor's protocol ID
- 3125055
- Status last verified
- Feb 2015
- First submitted
- 29 Jan 2015
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
- ClinicalTrials.gov ID
- NCT02362581
- Acronym / sponsor ID
- 3125055
- Conditions
- Prophylaxis, Hemophilia A
- Keywords
- Prophylaxis treatment, On demand treatment, Severe hemophilia A, Moderate hemophilia A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On demand treatment, prophylaxis treatment | Experimental | Other: prophylaxis treatment, on demand treatmentOn 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 |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 6 months to 18 years
- Diagnosis severe and moderate hemophilia A
Key exclusion criteria (2 listed)
- platelet < 100,000/mm3
- No factor VIII inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prophylaxis treatment, on demand treatmentAlso: Hemofil M | Other | On demand treatment, prophylaxis treatment |
Primary outcome
Number of bleeding episodes require treatment
Time frame: one year
number of school days lost
Time frame: one year
Number of admission days
Time frame: one year
3 secondary outcomes
Joint scores
Time frame: one year
Quality of life score
Time frame: one year
Amount of Facter VIII concentration used
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darintr Sosothikul, Asso professer principal investigator
pediatric Hemato-Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prophylaxis treatment, on demand treatment in people with Prophylaxis and Hemophilia A, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bleeding episodes require treatment (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.