6 completed, 3 unknown, 1 recruiting. 4 Phase 2, 1 Not applicable, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 2, Recruiting 1, Unknown 1 |
| Not applicable | 1 | Completed 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease Hydroxycarbamid - Sickle Cell Disease | Phase 2 | Recruiting | Theravia | 50 | 2025-01-21 | 2026-10-01 |
| Acceptability of a New Paediatric Formulation of Hydroxycarbamide in Children With Sickle Cell Disease. Hydroxycarbamide - Sickle Cell Disease | Phase 2 | Completed | Theravia | 33 | 2022-07-08 | 2022-11-23 |
| A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Hydroxycarbamide in Healthy Volunteers Hydroxycarbamide dispersible tablets, Hydroxycarbamide film-coated tablet - Healthy Volunteers | Phase 1 | Completed | Theravia | 28 | 2021-07-30 | 2026-09-29 |
| ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study Hydroxycarbamide - Sickle Cell Disease | Unknown | Theravia | 2093 | 2020-08-21 | 2024-08-27 | |
| SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial) Hydroxycarbamide, Placebo Oral Tablet - Sickle Cell Disease | Phase 2 | Completed | Theravia | 86 | 2019-05-28 | 2025-05-14 |
| Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease micro- and macro-circulatory vascular remodelling measures not practice in routine care, Biological measures not practice in routine care - Sickle Cell Disease | Not applicable | Completed | Theravia | 44 | 2016-05-17 | 2020-01-09 |
| Validation of a Predictive Score of Acute Chest Syndrome Vaso Occlusive Crisis, Acute Chest Syndrome | Unknown | Soutien aux Actions contre les Maladies du Globule Rouge | 800 | 2016-01-01 | 2022-12-13 | |
| Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment. Hydroxycarbamid - Central Retinal Vein Occlusion, Non-Ischemic | Phase 2 | Unknown | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | 30 | 2015-12-01 | 2016-11-28 |
| Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH) Siklos - Sickle Cell Disease, Renal Function Disorder | Phase 4 | Completed | Theravia | 40 | 2015-09-03 | 2021-10-12 |
| European Sickle Cell Disease Cohort - Hydroxyurea Siklos - Sickle Cell Disease | Completed | Theravia | 1906 | 2009-01-01 | 2020-03-19 |
Anemia, Sickle Cell (7) · Acute Chest Syndrome (1) · Albuminuria (1) · Retinal Vein Occlusion (1) · Vaso-Occlusive Crises (1)
Hydroxyurea (7)
France (9) · French Guiana (3) · Guadeloupe (3) · Martinique (3) · Germany (2) · Greece (2) · Italy (2) · Côte d’Ivoire (1) · Mali (1) · Reunion (1) · Senegal (1) · United Kingdom (1)
Annelize Koch, MD (1) · Josephine Brice, MD (1) · Mariane de Montalembert, MD (1) · Mariane de Montalembert, MD, PhD (1) · Pablo Bartolucci, Pr (1) · Vincent Audard, Pr (1)