EUCTR2013-003714-40-GB进行中（未招募）1 期
Hydroxychloroquine in pediatric ILDSTART randomized controlled in parallel-group, then switch placebo to active drug, and STOP randomized controlled in parallel-group to evaluate the efficacy and safety of hydroxychloroquine (HCQ) - HCQ in pediatric ILD v2.0
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1) Patients should be clinically stable during baseline (between Visit 1 and 2) for inclusion into the study
- •a) Determined by SpO2 in room air for patients on room air or on O2-supplement; the absolute difference on SpO2 is expected not to be = 5% between Visit 1 and 2. For patients on respiratory support, the summary key parameters should not change = 20% between Visit 1 and 2
- •b)No major changes in other medications between Visit 1 and 2
- •2) Mature newborn = 37 weeks of gestation, age = 3 wks or
- •infants and children (till age 18 y) or
- •previously preterm (= 37 weeks of gestation) babies or children and adults of all ages if chILD genetically diagnosed
- •3) diagnosis of chronic (= 3 wks of duration) diffuse parenchymal lung disease (DPLD = chILD), defined in at least one of the following ways:
- •a)chILD genetically diagnosed
- •b)chILD histologically diagnosed
- •c)chILD clinically diagnosed
- •4) Start block: no HCQ treatment in the last 12 weeks
- •Stop block: stable HCQ treatment for at least the last 12 weeks
- •5) Ability of subject or/and legal representatives to understand what the trial involves and the consequences
- •6) Signed and dated informed consent from the subject or their legal representative.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •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
- •-chILD primarily related to developmental disorders
- •-chILD primarily related to growth abnormalities reflecting deficient alveolarisation
- •-chILD related to chronic aspiration
- •-chILD related to immunodeficiency
- •-chILD related to abnormalities in lung vessel structure
- •-chILD related to organ transplantation/organ rejection/GvHD
- •-chILD related to recurrent infections
- •-Acute severe infectious exacerbations
- •-Planned changes in steroid therapy in the next 8 weeks
- •-Prednisone or Prednisolone as continuous medication =2mg/kgbw/d
- •-Known hypersensitivity to HCQ, or other ingredients of the tablets
- •-Proven retinopathy or maculopathy
- •-Glucose-6-phosphate-dehydrogenase deficiency resulting in favism or hemolytic anemia
- •-Myasthenia gravis
- •-Hematopoetic disorders
- •-Pregnancy and lactation
- •-Participation in other clinical trials during the present clinical trial or not beyond the time of 4 half-lives of the medication used, at least one week.
- •-Hereditary galactose intolerance, lactase deficiency or glucose-galactose-malabsorption
- •-Renal insufficiency at screening, defined as glomerular filtration rate (GFR)
- •-Liver disease,
- •-Gastrointestinal disorder, haematological disorder, epilepsy or other neurological disorder, psoriasis, porphyria at the discretion of the treating physician
- •-Simultaneous prescription of other potentially nephrotoxic or hepatotoxic medication at the discretion of the treating physician
- •-Medical or psychological condition that would not permit completion of the trial or signing of informed consent
研究者
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