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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001786-93 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tpo-RA discontinuation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tpo-RA discontinuation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | the criteria of response will be defined as the following:
| week 24 (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of overall response after Tpo-RAs discontinuation | response and complete response | 24 and 52 weeks |
| The duration of overall response after Tpo-RAs discontinuation. | response and complete response |
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Inclusion Criteria:
Exclusion Criteria:
1) Anticoagulation or anti-platelet treatment 2) Recent treatment with corticosteroids ± intravenous immunoglobulins (less than 2 months) 3) Rituximab or splenectomy within the 2 months preceding the Tpo-RA initiation 4) Rituximab or splenectomy after Tpo-RA initiation/RA initiation 5) Previous failure of Tpo-RA discontinuation 6) Pregnant or breastfeeding women 7) No affiliation to a social security scheme or other social protection scheme 8) Inability or refusal to understand or refusal to sign the informed consent from study participation 9) Patient deprived of freedom or under legal protection (guardianship, curatorship) 10) Hypersensitivity to Romiplostin or to any of the excipients or to E. coli derived proteins
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| Name | Affiliation | Role |
|---|---|---|
| Matthieu Mahevas, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri-Mondor Hospital | Créteil | 94010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39476101 | Derived | Cottu A, Guillet S, Viallard JF, Riviere E, Cheze S, Gobert D, Neel A, Graveleau J, Marolleau JP, Lefrere F, Moulis G, Lega JC, Moignet-Autrel A, Robbins A, Crickx E, Boutin E, Noel N, Malphettes M, Galicier L, Audia S, Bonnotte B, Lambotte O, Fain O, Gerfaud-Valentin M, Terriou L, Martis N, Morin AS, Perlat A, Le Gallou T, Roy-Peaud F, Puyade M, Comont T, Limal N, Languille L, Michel M, Godeau B, Mahevas M. Long-term follow-up of the STOPAGO study. Blood. 2025 Jan 9;145(2):244-247. doi: 10.1182/blood.2024025707. | |
| 36893453 |
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|
| 24 and 52 weeks |
| The number of bleeding events during the reduction period and along the study period at weeks 4, 8, 12,24,36, 52 | Safety assess of Tpo-RAs discontinuation | at weeks 4, 8, 12,24,36, 52 |
| The rate of the response to a new course of Tpo-RAs in case of relapse after Tpo-RAs discontinuation at one year | Rate of the response in case of relapse | 52 weeks |
| The delay of the response to a new course of Tpo-RAs in case of relapse after Tpo-RAs discontinuation | Delay of the response in case of relapse | 52 weeks |
| To identify predictive factors, for overall prolonged response | Search for predictive factor of response | Weeks 24 |
| Derived |
| Guillet S, Crickx E, Azzaoui I, Chappert P, Boutin E, Viallard JF, Riviere E, Gobert D, Galicier L, Malphettes M, Cheze S, Lefrere F, Audia S, Bonnotte B, Lambotte O, Noel N, Fain O, Moulis G, Hamidou M, Gerfaud-Valentin M, Marolleau JP, Terriou L, Martis N, Morin AS, Perlat A, Le Gallou T, Roy-Peaud F, Robbins A, Lega JC, Puyade M, Comont T, Limal N, Languille L, Zarrour A, Luka M, Menager M, Belmondo T, Hue S, Canoui-Poitrine F, Michel M, Godeau B, Mahevas M. Prolonged response after TPO-RA discontinuation in primary ITP: results of a prospective multicenter study. Blood. 2023 Jun 8;141(23):2867-2877. doi: 10.1182/blood.2022018665. |