Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

TTP - Thrombotic Thrombocytopenic Purpura Clinical Trial

Official title:

Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950750
• Other study ID #: eTTP-THD
• Status: Recruiting
• Start date: December 21, 2022
• Est. completion date: December 21, 2026

Study information

• Verified date: July 2023
• Source: Turkish Hematology Association
• Contact: ilker kurkcu
• Phone: +905326354515
• Email: ilker.kurkcu[@]sentez-cro.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)

Description:

Because of the non-interventional nature of the study, there is no predefined treatment protocol. The patients will be treated according to the routine practices of the centers. In observational drug studies, the drug to be administered in treatment should be prescribed and patient's treatment should be started prior to study inclusion decision is made as a principle. The participating physician will continue to treat the patients according to their routine practices. Not only newly diagnosed patients, all aTTP patients within participated centers will be recruited and 12 months follow-up data will be collected. 21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: December 21, 2026
• Est. primary completion date: December 21, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed as aTTP after 01.01.2015
• Patients with ADAMS13<10%
• Thrombocytopenia (<100.000)
• Coombs (-)
• Microangiopathic hemolytic amenia
• 18 years and older

Exclusion Criteria:

• Patient who does not sign informed consent form

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic
• TTP - Thrombotic Thrombocytopenic Purpura

Locations

Country	Name	City	State
Turkey	Baskent Universtiy Faculty of Medicine	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Turkish Hematology Association	Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes	Median number of episodes will be given	Through study completion, an average of 4 years
Primary	To describe treatment patterns among TTP patients	All treatments received by patients will be expressed as percentages	Through study completion, an average of 4 years
Secondary	To describe demographic characteristics of TTP patients	Age, sex, family history, comorbidities will be expressed as percentages	24 months