EUCTR2013-004132-29-DK进行中（未招募）不适用
An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, efficacy and safety of once daily dosing compared to twice daily dosing of Orfadin in patients diagnosed with hereditary tyrosinemia type 1
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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. Male and female patients of all ages diagnosed with HT-1.
- •2. Patients currently well-controlled, as judged by the investigator, on twice daily (or more frequent) dosing with Orfadin.
- •3. Stable lab values, including liver values <2 ULN (ALP, ALT, AST, bilirubin, INR).
- •4. Women of childbearing potential willing to use adequate contraception
- •5. Signed informed consent/assent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients who have been previously treated with once daily Orfadin, even if later converted to twice daily dosing.
- •2. Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- •3. Enrollment in another concurrent clinical interventional study within three months prior to inclusion in this study.
- •4. Pregnant women.
- •5. Lactating women.
- •6. Previous liver transplantation
- •7. Patients who have recently (past 4 weeks prior to inclusion) started any new medication for a previously undiagnosed illness/disease.
- •8. Known hepatitis B, hepatitis C or HIV infection.
- •9. Foreseeable inability to cooperate with given instructions or study procedures.
研究者
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