Acquired HaemophiliaEHEMNCT01403740
Turkish Acquired Haemophilia Registry
An observational study of Acquired Haemophilia, run by Turkish Society of Hematology at 1 site in Turkey (Türkiye).
Trial summary
Turkish Acquired Haemophilia Registry is a database in which information about clinical features and therapeutic management of acquired haemophilia is collected in Turkey.This is a multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for acquired haemophilia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Haemophilia
- What is being tested?
- rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2011to Aug 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acquired haemophilia diagnosed and/or treated in haematology clinics
Who may be able to join
- Acquired haemophilia diagnosis, written consent
Who cannot join
- Being unable to give written consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Haematology Clinic
Edirne, 22030
Muzaffer A Demir, Prof, 902842351041, mdemir@trakya.edu.tr
Dilek Solakoglu, MD, 902123253232, dileksolakoglu@cortexiletisim.com
About this study
Official title: Observational Acquired Haemophilia Registry
Turkish Acquired Haemophilia Registry is a database in which information about clinical features and therapeutic management of acquired haemophilia is collected in Turkey.This is a multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for acquired haemophilia. Patients will be registered and the response to different therapies, details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or other factors and treated for acquired haemophilia can be entered on the registry. Patients will be treated according to local practice. No additional tests or procedures are required by the registry. The retrospective period will not be time-limited and data will be collected from those recorded in the hospital notes. The prospective period will begin in September 1.2011, and will last for two years.
- Conditions
- Acquired Haemophilia
- Being tested
- rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin
- Keywords
- acquired haemophilia, factor VIII
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, CyclosporinDrug
According to local clinical standards
| Study group | Role | What they receive |
|---|---|---|
| Acquired haemophilia patients | Not described Receives: Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired HaemophiliaStudies of the same condition, open and under way.
- 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
- Observational
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Hematology
- Sponsor type
- University, hospital or other
- Investigators
- Muzaffer A Demir, Prof, Principal investigator, THD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403740
- Sponsor's protocol ID
- 2011/HEM/001
- Acronym
- EHEM
- Status last verified
- Jun 2011
- First submitted
- 26 Jul 2011
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Acquired Haemophilia Registry
- ClinicalTrials.gov ID
- NCT01403740
- Acronym / sponsor ID
- EHEM / 2011/HEM/001
- Conditions
- Acquired Haemophilia
- Keywords
- acquired haemophilia, factor VIII
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Turkish Society of HematologyUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 27 Jul 2011 (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.
Turkish Acquired Haemophilia Registry is a database in which information about clinical features and therapeutic management of acquired haemophilia is collected in Turkey.This is a multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for acquired haemophilia. Patients will be registered and the response to different therapies, details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or other factors and treated for acquired haemophilia can be entered on the registry. Patients will be treated according to local practice. No additional tests or procedures are required by the registry. The retrospective period will not be time-limited and data will be collected from those recorded in the hospital notes. The prospective period will begin in September 1.2011, and will last for two years.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acquired haemophilia patients | – | Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acquired haemophilia diagnosed and/or treated in haematology clinics
Key inclusion criteria (1 listed)
- Acquired haemophilia diagnosis, written consent
Key exclusion criteria (1 listed)
- Being unable to give written consent
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 |
|---|---|---|
| rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, CyclosporinAccording to local clinical standards | Drug | Acquired haemophilia patients |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
Related trials for Acquired Haemophilia
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingObservational study
A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea
Acquired Hemophilia A
Not yet recruiting
A Study of Bometase Alfa for Bleeding Control in Acquired Hemophilia A
Acquired Hemophilia A
RecruitingObservational study
A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
Acquired Hemophilia A
Active, not recruitingPhase 2
Emicizumab in Patients With Acquired Hemophilia A
Acquired Hemophilia A
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.
Muzaffer A Demir, Prof principal investigator
THD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Haemophilia, run by Turkish Society of Hematology at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2011. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Solakoglu, MD (902123253232, dileksolakoglu@cortexiletisim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Jul 2011.