Turkish Acquired Haemophilia Registry

Acquired Haemophilia Clinical Trial

— EHEM  

Official title:

Observational Acquired Haemophilia Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01403740
• Other study ID #: 2011/HEM/001
• Status: Not yet recruiting
• Phase: N/A
• First received: July 26, 2011
• Last updated: July 26, 2011
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: June 2011
• Source: Turkish Society of Hematology
• Contact: Dilek Solakoglu, MD
• Phone: 902123253232
• Email: dileksolakoglu[@]cortexiletisim.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health Drugs and Pharmacy Administration
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acquired haemophilia diagnosis, written consent

Exclusion Criteria:

• Being unable to give written consent

Study Design

N/A

Related Conditions & MeSH terms

• Acquired Haemophilia
• Hemophilia A

Intervention

Drug:
• rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin
According to local clinical standards

Locations

Country	Name	City	State
Turkey	Trakya University Haematology Clinic	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Society of Hematology

Country where clinical trial is conducted

Turkey,