EUCTR2017-004568-37-GB进行中（未招募）1 期
A prospective open label, pharmacokinetic study of an oral hydroxyurea solution in children with sickle cell anemia - Pharmacokinetics of oral hydroxyurea solution
ova Laboratories Limited0 个研究点目标入组 25 人开始时间: 2018年9月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
入选标准
- •1. Male or female aged from 6 months to 17.99 years of age (i.e. to
- •the day before 18th birthday).
- •2. Diagnosis of sickle cell anemia (HbSS and HbS0).
- •3. Parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study. Where applicable, the child should assent to undergo blood sampling for pharmacokinetic and biochemistry purposes and to allow physiological measurements to be made.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •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
- •1. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study.
- •2. Hydroxycarbamide use within 6 months before enrolment.
- •3. Renal insufficiency (either microalbuminuria, from spot urine or albumin/creatinine ratio [ACR value of > 0.03] and/or Proteinuria, from albumin specific dipstick) (for Proteinuria UTI will be excluded by culture/MSU).
- •4. Clinical evidence of hepatic compromise with ALT more than 3 times the upper limit of normal (a temporary swing in ALT will not result in exclusion).
- •5. Other significant organ system dysfunction based on the site investigator’s discretion.
- •6. Active infections: bacterial (as confirmed by culture), viral or fungal (tuberculosis, malaria, active hepatitis, osteomyelitis);
- •7. Active chronic leg ulcers.
- •8. Known allergy to oral hydroxycarbamide solution or any of the excipients.
- •9. Positive pregnancy test for females of child-bearing potential before initiation of treatment, unless participant is sexually abstinent.
- •Note: true abstinence is considered as being in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of
- •contraception.
- •10. Inadequate contraception measures in sexually active females and males of child-bearing age (see section 5.12).
- •11. Currently breastfeeding.
- •12. Participating in another clinical trial of an IMP.
研究者
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