ITP Registry and Accompanying Biospecimen Collection
ConditionImmune Thrombocytopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJena University Hospital
About this trial
The objective of this ITP registry is to collect clinical information, including biosampling, from consenting patients with a variety of ITPs at different points in the course of their disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary or secondary Immune Thrombocytopenia (ITP)
Age ≥18 years
signed declaration of consent
Disqualifiers
diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)
no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)
Trial population
Patients with Immune thrombocytopenia (ITP) which is a rare hematologic disorder that can lead to a greater risk of bleeding or a prolonged bleeding time due to an autoimmune-mediated deficiency of platelets. There is a distinction between a primary form, in which no triggering cause is identifiable, and secondary forms, which may for example occur in the context of systemic autoimmune diseases or drug-induced.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
epidemiological data on ITP - Incidence
Incidence: number of reported ITP, estimate incidence by zip code area
Time frame
At enrollment2
epidemiological data on ITP - Age
Age (year of birth)
Time frame
At enrollment3
epidemiological data on ITP - Sex distribution
Sex distribution: female, male
Time frame
At enrollment4
Description of the causes of ITP
causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others)
Time frame
At enrollmentSecondary outcomes
1
Recording of clinical characteristics of affected patients - Disease stage
bleeding severity WHO-CTCAE Grade 1-4
Time frame
At enrollment, 6 months, annually up to 5 years2
Recording of clinical characteristics of affected patients- platelet counts
platelet counts in Gpt/l
Time frame
At enrollment, 6 months, annually up to 5 years3
Recording of clinical characteristics of affected patients -disease manifestation at diagnosis
Localisation of bleeding and severity (WHO-CTCAE Grading)
Time frame
At enrollment4
Bleeding events
Bleeding events (yes, no)
Time frame
At enrollment, 6 months, annually up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jena University Hospital
Lead sponsor
University Hospital Dresden
Collaborator
Novartis
Collaborator
Swedish Orphan Biovitrum
Collaborator
Grifols Biologicals, LLC
Collaborator
Amgen
Collaborator
argenx
Collaborator
Source ClinicalTrials.gov