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最高研发阶段批准上市 |
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首次获批日期2013-09-12 |
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最高研发阶段批准上市 |
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首次获批日期1973-09-06 |
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最高研发阶段批准上市 |
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首次获批日期1967-12-07 |
Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease: a Single-group, Non-randomised, Open-label Study (KID-BID)
The purpose of this interventional, phase II, national, multicentric, non-randomised, open-label study is to evaluate the pharmacokinetics (PK), efficacy and safety of Hydroxycarbamide Paediatric dispersible tablets with a twice daily dosing regimen in children with Sickle Celle Disease between 9 months to 11 years of age.
Participants will:
* Take Hydroxycarbamide twice a day every day for 12 months
* Visit the clinic at screening, baseline, 1, 3, 6, 9 and 12 months
Phase I Trial: RD 785.35736 (ADR-UK-23-1)
ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension
As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.
100 项与 Theravia Pharma SAS 相关的临床结果
0 项与 Theravia Pharma SAS 相关的专利(医药)
100 项与 Theravia Pharma SAS 相关的药物交易
100 项与 Theravia Pharma SAS 相关的转化医学