EUCTR2018-002633-38-GB进行中（未招募）1 期
An open label phase I/IIa trial repurposing carbamazepine (CBZ) for the treatment of skeletal dysplasia in children. - MCDS-Therapy
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Participants where a pathogenic mutation in the gene encoding the COL10A1 protein has been identified by sequence analysis
- •Ambulant at the time of consent/assent, with open epiphyses
- •Willing to attend for safety monitoring assessments
- •Willing and able to adhere to the trial visit schedule and other protocol requirements.
- •Capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant’s behalf (e.g. parent or legal guardian of a child under 16 years of age)
- •Written informed consent signed (by parent(s)/legal guardian and/or the subject, according to the local regulations)
- •The patient, if female and of childbearing potential, must have a negative pregnancy test [urine beta-human chorionic gonadotropin (ß-hCG)] at baseline and agree to regular pregnancy testing during the trial.
- •Sexually active female patients of childbearing potential are required to practice true abstinence in line with their preferred and usual lifestyle or use two acceptable effective methods of contraception, a barrier method such as a condom or occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository and an established non-barrier method such as oral, injected, or implanted hormonal methods (hormonal preparations must contain not less than 50µg oestrogen) use of some alternative non-hormonal method of contraception should be considered, an intrauterine device or intrauterine system for the entire duration of the treatment period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients who have reached skeletal maturity
- •Patients who have had a prior adverse reaction to carbamazepine or similar drugs such as oxcarbazepine, or to any related tricyclic antidepressants.
- •Patients known to have atrioventricular block
- •Patients who have a history of bone marrow suppression/depression
- •Patients who have evidence of chronic hepatic or renal impairment
- •Patients who have acute intermittent porphyria
- •Patients who have received a monoamine oxidase inhibitor within 14 days of commencing therapy
- •Patients who have abnormal blood screening results at the time of treatment initiation will be excluded unless the Investigator believes the abnormality to be non-significant clinically
- •Patients of Han Chinese, Thai and other Asian origins who carry the HLA-B*1502 allele
研究者
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