Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
This is a single-center, prospective, controlled study with one eltrombopag treatment group
and 2 control groups, one on standard steroid treatment, and another one untreated.
The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on
shear-induced platelet activation.
STUDY DESIGN:
Single-center (Medical University Vienna), prospective, controlled study. Patients will be
recruited at the Division of Haematology and Haemostaseology at the Medical University in
Vienna, one eltrombopag treatment group and 2 control groups, one on standard steroid
treatment, another one untreated.
AIM OF THE STUDY:
To determine the effect of MPL agonists on shear-induced platelet activation. Data obtained
from patients treated with eltrombopag shall be compared to those from untreated patients and
patients on steroids. These investigations will extend previous studies that investigated
platelet function without in vitro activation in patients receiving eltrombopag.
PATIENTS:
Trial Population:
Total number of patients n=34: 12 on eltrombopag, 12 on corticosteroids and 10 without
treatment will be included in this trial.
Treatment with eltrombopag or corticosteroids. Eltrombopag starting dose: 25 mg/day,
increased as needed (to 50 mg or maximum 75 mg once daily) every 2 weeks to reach a platelet
count between 50,000-100000/µL and tapering the dosis if platelet count >= 100,000/µL.
Afterwards, if platelet count stable (tolerance +/- 20%), platelet control every 4 weeks,
otherwise weekly.
Prednisolone starting dose: 1 mg/kg/day to reach a platelet count between 50,000-100,000 /µL
tapering of the dosage if platelet count >= 100,000/µL.
Laboratory Investigations:
In the eltrombopag group and in the newly treated prednisolone group platelet counts and
platelet function tests will be performed at planned visits.
In patients who are on continuous corticosteroids (part of control group I) and untreated
patients (control group II), which have a platelet count between 50,000 and 100,000/µL
platelet counts, reticulated platelets, platelet function tests and platelet antibodies will
be studied at entry and after 4 weeks (+ 5 days).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05220878 -
Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP
|
Phase 3 | |
| Completed |
NCT00451594 -
High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
|
Phase 3 | |
| Withdrawn |
NCT01276561 -
Single Incision Versus Standard Laparoscopic Splenectomy
|
N/A | |
| Completed |
NCT01713855 -
Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
|
N/A | |
| Recruiting |
NCT03465020 -
Investigation on a Dynamic Cohort of Italian Patients With Active ITP
|
||
| Completed |
NCT00603642 -
P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
|
Phase 3 | |
| Completed |
NCT01143038 -
Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
|
Phase 2 | |
| Not yet recruiting |
NCT04128358 -
Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
|
N/A | |
| Completed |
NCT00128882 -
Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D
|
Phase 2 | |
| Completed |
NCT01525836 -
rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
|
Phase 3 | |
| Completed |
NCT00828750 -
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
|
Phase 3 | |
| Completed |
NCT00625443 -
Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
|
Phase 2 | |
| Completed |
NCT00475423 -
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
|
Phase 2 | |
| Completed |
NCT00454857 -
Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
|
N/A | |
| Completed |
NCT00102323 -
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
|
Phase 3 | |
| Completed |
NCT05492409 -
Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
|
Phase 3 | |
| Terminated |
NCT01433978 -
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)
|
Phase 3 | |
| Withdrawn |
NCT01443351 -
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
|
||
| Completed |
NCT01520909 -
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
|
Phase 3 | |
| Not yet recruiting |
NCT06287567 -
Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)
|
Phase 4 |