EUCTR2018-001496-20-DE进行中（未招募）1 期
A multi-national, multi-centre, double-masked, placebo-controlled proof of concept trial to evaluate the safety and efficacy of oral soraprazan in Stargardt disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Katairo GmbH
- 入组人数
- 90
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
- •Elevated qAF in at least one eye at screening (value =300 Units).
- •Male or female of any ethnicity and = 18 years old.
- •Onset of STGD disease before the age of 45 years
- •Visual acuity of the study eye: BCVA 0.2-0.8 (decimal unit).
- •Clinical diagnosis of typical autosomal recessive Stargardt’s macular dystrophy (STGD1).
- •Genetic report indicating at least two ABCA4 mutations (one with confirmed pathogenesis by a certified lab, one reported previously).
- •Study eye must have clear ocular media and adequate pupillary dilation, including no allergy to dilating eye drops and with sufficient fixation to permit good quality retinal imaging.
- •Able and willing to comply with study requirements, restrictions and instructions and is likely to complete the 12-months study.
- •Signed and dated informed consent form.
- •Female subjects of childbearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. Male and female subjects documented as being of non-child bearing potential (e.g. infertile, surgically sterile, postmenopausal) are exempt from the contraceptive requirements.
- •Willing to avoid excessive exposure to sun light (e.g. by using a hat, UV absorbing sunglasses and sunscreen with a minimum SPF of 30).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Intolerance to acid pump antagonists (APAs).
- •Hypersensitivity to soraprazan or to any of the excipients.
- •Intake of prohibited medications/supplements (supplements containing vitamin A or beta-carotene, medications to treat any liver disease, or oral retinoid medications) within 28 days prior to screening and throughout the study.
- •Intake of other drugs with a pH dependent absorption, e.g. ketoconazole.
- •Breastfeeding, pregnant, or positive urine pregnancy test at screening or visit 2 (first intake of Investigational Medicinal Product, IMP).
- •At screening, clinically significant abnormal haematology or biochemistry findings. Levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin >1.5 x ULN (upper limit of normal) at screening will lead to exclusion.
- •Acute or unstable severe disease or history of disease which in the opinion of the investigator would preclude participation in the study.
- •Active or history of an additional ocular disorder in the primary study eye that, in the opinion of the investigator, may confound the study results. These include, but are not limited to, any reason that might interfere with the imaging techniques used in the study (such as optic media opacity or poor pupil dilatation), inflammatory eye disease, other retinal disorders besides STGD, confirmed glaucoma or baseline intraocular pressure of =25mmHg, optic neuritis, high myopia (>8D spherical equivalent), amblyopia.
- •Intraocular surgery or injections in the primary study eye within 180 days of the screening visit.
- •Clinically significant abnormal electrocardiogram (ECG), or a corrected QT interval (QTc) of =450 ms in males or =470 ms in females.
- •Participation in any other investigational clinical trial within 28 days of the screening visit.
研究者
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