ClinicalTrials.gov record NCT05950750

Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jul 18, 2023, about 3 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationTurkey
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a non‑interventional registry collecting clinical and treatment data from adults diagnosed with TTP. Participants' routine care continues; data from past diagnoses and treatments may be included and each participant is followed for at least 12 months. No study treatment is assigned.

What it is studying. Collects real-world data to describe how often TTP episodes occur, what treatments patients receive, and patient characteristics.

What the researchers hope to learn. Describe the median number of TTP episodes; document treatment patterns received by patients (reported as percentages); and summarize demographic and clinical characteristics of the TTP population.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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)

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants' medical and treatment information will be collected and entered into an electronic case report form; past diagnosis and treatment records may be used. The study is non-interventional: your treating physician continues routine care and the study does not assign treatments (for observational drug cases, treatment is expected to have been started before inclusion). You will be followed for at least 12 months (or until the study ends or you withdraw consent). Data collected aim to describe episodes, treatment patterns and patient characteristics.

How the study is structured. A prospective, observational registry (cohort) that does not assign treatments. Data are entered into electronic case report forms. The study includes people already diagnosed as well as new cases, follows each participant for at least 12 months, and has a planned target sample size and recruitment period recorded in the registry.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Turkey. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on thrombotic thrombocytopenic purpura

Important dates

Study start
Dec 21, 2022
Primary completion
Dec 21, 2023 (estimated)
Study completion
Dec 21, 2026 (estimated)
Target enrollment
960 participants (estimated)
Last updated on registry
Jul 18, 2023
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Turkish Hematology Association
Collaborators
  • Sanofi

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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