Thrombotic Thrombocytopenic PurpuraRGTTPNCT05389007
.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)
An observational study of Thrombotic Thrombocytopenic Purpura, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jul 2016to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to include all patients with TTP in Germany.
Who may be able to join
- Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18.
- Patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative.
- Written informed consent of the patient.
Who cannot join
- Patients who are not able to understand the German or English language.
- Patients who are permanently unable to communicate and who are not accompanied by a legal representative.
Trial locations and contacts
1 site in 1 country.
Charis v. Auer-Wegener contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Mainz, Hematology
Mainz, 55131
Charis v. Auer-Wegener, charis.von-auer@unimedizin-mainz.de
About this study
Official title: German TTP- Registry- Prospective Cohort of Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP): Pathophysiology, Diagnosis, Treatment and Follow-Up
Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.
Read the detailed description
1.) Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry and 2.) Investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive markers for morbidity and mortality
Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start8 Jul 2016
- Primary completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 156 participants
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charis v. Auer, Johannes Gutenberg University Mainz
- Investigators
- Charis v. Auer-Wegener, Principal investigator, Universitätsmedizin Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389007
- Sponsor's protocol ID
- RGTTP
- Acronym
- RGTTP
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German TTP- Registry- Prospective Cohort of Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP): Pathophysiology, Diagnosis, Treatment and Follow-Up
- ClinicalTrials.gov ID
- NCT05389007
- Acronym / sponsor ID
- RGTTP / RGTTP
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 8 Jul 2016
- Primary completion
- 1 Jul 2025 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.
Detailed description
1.) Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry and 2.) Investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include all patients with TTP in Germany.
Key inclusion criteria (3 listed)
- Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18.
- Patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative.
- Written informed consent of the patient.
Key exclusion criteria (2 listed)
- Patients who are not able to understand the German or English language.
- Patients who are permanently unable to communicate and who are not accompanied by a legal representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive markers for morbidity and mortality
Time frame: 3 years
Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charis v. Auer-Wegener contact
Charis v. Auer-Wegener principal investigator
Universitätsmedizin Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Thrombocytopenic Purpura, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charis v. Auer-Wegener (charis.von-auer@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive markers for morbidity and mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.