EUCTR2018-004729-97-NL进行中（未招募）1 期
Randomized, controlled growth hormone study in children and adolescents with a Prader-Willi-like phenotype, followed by a two year open-label growth hormone study - effects on body composition, growth, psychosocial development and quality of life
Dutch Growth Research Foundation0 个研究点目标入组 64 人开始时间: 2019年6月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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
- 性别
- All
入选标准
- •- Prader-Willi-like phenotype, according to the PWL criteria (see below), or with a proven molecular diagnosis of a uniparental disomy of chromosome 14 (mUPD14), or a mutation or duplication in the 15q11.2-q13 region (PWS-critical region).
- •- Absence of a molecular diagnosis of PWS. This includes a type 1 (from breakpoint 1 to breakpoint 4) or type 2 (from breakpoint 2 to breakpoint 4) deletion, a uniparental disomy or imprinting center defect of the 15q11.2-q13 region.
- •o Boys: 4 to 16 years
- •o Girls: 4 to 14 years.
- •- Written informed consent.
- •PWL criteria:
- •The PWL phenotype is present in case of the following symptoms:
- •Hyperphagia and/or rapid weight gain between the ages of 1 and 8 years
- •Developmental/psychomotor delay (IQ<85 and/or enrolment in a school for children with special needs)
- •One or more of the following symptoms:
- •o Infantile central hypotonia
- •o Behavioural problems (temper tantrums, (auto)aggression, autistic and/or obsessive compulsive behaviour
- •o Poor speech
- •o Vision abnormalities (e.g. myopia, esotropia)
- •o Short stature (as defined by < -2SD-score, or -2SD relative to the target height)
- •o Small hands and feet for height and/or age.
- •N.B. Patients diagnosed with UPD14 or a mutation/duplication in the 15q11.2 (Prader-Willi critical) region do not have to meet the PWL-criteria.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 64
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Non-cooperative behavior
- •- Extremely low dietary intake of less than the minimally required intake according to WHO
- •- Use of medication to reduce weight
- •- BMI > +4SD
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