EUCTR2020-004604-33-PL进行中（未招募）1 期
Open label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients - TR-004 UNITED Study
nivar Solutions, B.V.0 个研究点目标入组 50 人开始时间: 2021年6月4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
- 50
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. Patient (or a representative) must provide written,
- •informed consent before the start of any study
- •procedures.
- •2. Male and female patient aged = 5 years at time of
- •3. Diagnosis of WD previously determined by the
- •physician based on a Leipzig score = 4.
- •4. Patient (= 18 years) has previously been treated with
- •D-penicillamine for WD.
- •5. Patient (< 18 years) has previously been treated with
- •D-penicillamine or zinc for WD.
- •6. For female patients of childbearing potential, a negative
- •pregnancy test at the Screening visit and the Baseline
- •visit is required. In addition, a highly effective method
- •(failure rate <1%) of birth control must be used during
- •the study which includes (but is not limited to) the
- •- vasectomized partner (at least 6 months prior to
- •- oral, patch, or injected contraceptives, or vaginal
- •hormonal device (i.e. NuvaRing®), in use for at least 3 consecutive months prior to study dosing
- •and throughout the study duration;
- •- implanted or intrauterine contraceptives in use
- •for at least 6 consecutive months prior to study
- •dosing and throughout the study duration;
- •- abstinence (must agree to use a highly effective
- •method if they become sexually active during
- •the study).
- •7. Patient is considered to be able to complete study
- •requirements and attend the study visits, in the opinion
- •of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patient has evidence of uncontrolled liver disease,
- •including but not limited to:
- •a. New Wilson index (Dhawan Index) > 10
- •b. Alanine aminotransferase (ALT) > 5x upper limit of
- •normal (ULN)
- •c. Aspartate aminotransferase (AST) > 5x ULN
- •d. Model for End-Stage Liver Disease (MELD) score
- •> 13 (only applicable for patients that are = 12 years
- •e. Acute liver failure
- •f. Hepatic malignancy
- •2. Uncontrolled neurological disease according to the
- •judgement of the physician.
- •3. Patient has severe anaemia defined as hemoglobin of
- •4. Patient has a known intolerance, allergy or sensitivity to
- •trientine dihydrochloride, including any component of
- •the study medication.
- •5. Female patient is pregnant or lactating.
- •6.Any patients who lack the capacity to consent, including the parent(s) of a paediatric patient.
研究者
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