Rate of Prolonged Response After Stopping Thrombopoietin-receptor Agonists Treatment in ITP (STOP-AGO)
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|ClinicalTrials.gov Identifier: NCT03119974|
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : May 23, 2017
Thrombopoietin-receptor agonists (Tpo-RAs) have profoundly changed the management of ITP. However, today, there are no international recommendations concerning the long-term use of these costly, potentially pro-thrombotic agents, and that could induce bone marrow fibrosis in case of prolonged treatment. Tpo-RAs have been thought to play only a supporting role in ITP management. But our center along with many other research centers, have reported unexpected cases of durable remission after Tpo-RAs discontinuation in adult chronic ITP. In these retrospective studies, more than 20 % of patients were able to achieve prolonged remission.
The purpose of this study is to demonstrate that a substantial proportion of ITP patients may achieve a prolonged response after Tpo-RA discontinuation.
The investigators developed, in this study, a standardized procedure to discontinue Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of bleeding. In case of relapse after Tpo-RA discontinuation, the decision to start a new therapy will be based on the clinician's judgment.
|Condition or disease||Intervention/treatment||Phase|
|Persistent or Chronic ITP||Drug: Tpo-RA discontinuation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rate of Prolonged Response After Stopping Thrombopoietin-receptor Agonists Treatment in Immune Thrombocytopenia: a Prospective Multicenter Open Study|
|Actual Study Start Date :||April 18, 2017|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Drug: Tpo-RA discontinuation
a standardized strategy of dosage reduction will be implemented according to a predetermined scheme on persistent and/or chronic ITP patients who have previously achieved a stable and prolonged (> 2 months) complete response (platelets counts > 100 x 109/L) period on Tpo-RA treatment.
- The proportion of patients achieving an overall response (complete response and response) at week 24 (6 months). The criteria of response will be defined according to international terminology [ Time Frame: week 24 (6 months) ]
the criteria of response will be defined as the following:
- Response (R) will be defined as sustained platelet count >30x109/L in the absence of bleeding or use of any other ITP directed therapies between the week 0 (discontinuation) and week 24.
- Complete response (CR) by a platelet count > 100x 109/L in the absence use of any other ITP directed therapies between week 0 and week 24.
Patients will be considered as being non-responders (NR) if:
- Their platelet count is < 30 x 109/L between week 0 and week 24, but also, in the setting of this study if:
- They need a rescue therapy (a new course of corticosteroids and/or intravenous immunoglobulin) after inclusion.
- The rate of overall response after Tpo-RAs discontinuation [ Time Frame: 24 and 52 weeks ]response and complete response
- The duration of overall response after Tpo-RAs discontinuation. [ Time Frame: 24 and 52 weeks ]response and complete response
- The number of bleeding events during the reduction period and along the study period at weeks 4, 8, 12,24,36, 52 [ Time Frame: at weeks 4, 8, 12,24,36, 52 ]Safety assess of Tpo-RAs discontinuation
- The rate of the response to a new course of Tpo-RAs in case of relapse after Tpo-RAs discontinuation at one year [ Time Frame: 52 weeks ]Rate of the response in case of relapse
- The delay of the response to a new course of Tpo-RAs in case of relapse after Tpo-RAs discontinuation [ Time Frame: 52 weeks ]Delay of the response in case of relapse
- To identify predictive factors, for overall prolonged response [ Time Frame: Weeks 24 ]Search for predictive factor of response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119974
|Contact: Matthieu Mahevas, MD, PhD||(0)143812076 ext +email@example.com|
|Creteil, France, 94010|
|Principal Investigator:||Matthieu Mahevas, MD, PhD||Assistance Publique - Hôpitaux de Paris|