Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Sponsor

Turkish Hematology Association (Other)

Overall Status

Recruiting

CT.gov ID

NCT05950750

Collaborator

Sanofi (Industry)

960

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
TTP - Thrombotic Thrombocytopenic Purpura

Detailed 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)

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

960 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Actual Study Start Date :

Dec 21, 2022

Anticipated Primary Completion Date :

Dec 21, 2023

Anticipated Study Completion Date :

Dec 21, 2026

Arms and Interventions

Arm	Intervention/Treatment
All Patients Non interventional observational

Outcome Measures

Primary Outcome Measures

Number of episodes [Through study completion, an average of 4 years]
Median number of episodes will be given
To describe treatment patterns among TTP patients [Through study completion, an average of 4 years]
All treatments received by patients will be expressed as percentages

Secondary Outcome Measures

To describe demographic characteristics of TTP patients [24 months]
Age, sex, family history, comorbidities will be expressed as percentages

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent Universtiy Faculty of Medicine	Ankara		Turkey

Sponsors and Collaborators

Turkish Hematology Association
Sanofi

Investigators

Study Director: ilker kurkcu, Sentez-CRO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Turkish Hematology Association

ClinicalTrials.gov Identifier:

NCT05950750

Other Study ID Numbers:

eTTP-THD

First Posted:

Jul 18, 2023

Last Update Posted:

Jul 18, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Turkish Hematology Association

TTP

THD

Additional relevant MeSH terms:

Purpura

Purpura, Thrombocytopenic

Purpura, Thrombotic Thrombocytopenic

Study Results

No Results Posted as of Jul 18, 2023