TTP - Thrombotic Thrombocytopenic PurpuraNCT05950750
Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study
An observational study of TTP - Thrombotic Thrombocytopenic Purpura, run by Turkish Hematology Association at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TTP - Thrombotic Thrombocytopenic Purpura
- How many people
- 960 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2022to 21 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with TTP and signed an informed written consent will be included into the study. 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.
Who may be able to join
- Diagnosed as aTTP after 01.01.2015
- Patients with ADAMS13<10%
- Thrombocytopenia (<100.000)
- Coombs (-)
- Microangiopathic hemolytic amenia
- 18 years and older
Who cannot join
- Patient who does not sign informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent Universtiy Faculty of Medicine
Ankara
Sema Karakus, Prof, +905335476318, sema_karakus@hotmail.com
About this study
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)
Read the 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)
- Keywords
- TTP, THD
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Non interventional observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes
Median number of episodes will be given
Measured: Through study completion, an average of 4 years
To describe treatment patterns among TTP patients
All treatments received by patients will be expressed as percentages
Measured: Through study completion, an average of 4 years
Secondary outcomes (1)
To describe demographic characteristics of TTP patients
Age, sex, family history, comorbidities will be expressed as percentages
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start21 Dec 2022
- Primary completion21 Dec 2023 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TTP - Thrombotic Thrombocytopenic PurpuraStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 960 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Turkish Hematology Association
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- ilker kurkcu, Study director, Sentez-CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950750
- Sponsor's protocol ID
- eTTP-THD
- Status last verified
- Jul 2023
- First submitted
- 31 Jan 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakus S, Bakanay SM, Kalayoglu Besisik S, Eskazan AE, Ayyildiz O, Gurkan E, Salim O, Karakus V, Guler N, Keklik M, Ozcebe OI, Ozkalemkas F, Ozkocaman V, Yilmaz U, Dadin S, Ucar MA, Sonmez M, Karakus A, Atas U, Koc LZ, Gunduz E, Kabukcu Hacioglu S, Unver Koluman B, Ozet G, Guney T, Fidan K, Karaagac Akyol T, Kikili CI, Demirkan F, Yavasoglu I, Dagtas S, Kestane M, Uskudar Teke H, Kocak Toprak S, Karatas A, Yagci M, Ozatli D, Ozkurt ZN, Ilhan O, Ar MC. Clinical Manifestations, Treatment Characteristics, and Clinical Outcomes in Patients with Immune Thrombotic Thrombocytopenic Purpura (iTTP) in a Real-World Setting: An Interim Analysis of the Turkish iTTP Registry. Turk J Haematol. 2025 Aug 29;42(3):203-212. doi: 10.4274/tjh.galenos.2025.2025.0134. Epub 2025 Jul 23.
PubMed 40699136