EUCTR2015-005051-28-Outside-EU/EEA进行中（未招募）1 期
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to less than 18 Years with Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 10
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
- •101 Subject’s legally acceptable representative has provided informed consent and
- •the subject has provided written assent based on local regulations and/or
- •guidelines prior to any study-specific activities/procedures being initiated.
- •102 Male or female subjects (aged 2 to less than 18 years) diagnosed with CKD and
- •sHPT and receiving maintenance haemodialysis or haemodiafiltration for
- •> 30 days prior to screening.
- •103 Subject must be on a dialysate calcium concentration of = 2.5 mEq/L
- •(1.25 mmol/L) for at least 1 month prior to enrollment and throughout the duration of the study.
- •104 Screening and Baseline serum PTH level > 200 pg/mL (21 pmol/L).
- •105 Subject must weigh = 7 kg at Baseline (Day -2).
- •106 Screening and Baseline serum corrected calcium from the local laboratory
- •= 9 mg/dL (2.25 mmol/L).
- •107 Subjects on anti-convulsant medication must be on a stable dose for 3 months.
- •108 Free of any disease or condition other than those diseases or conditions related to their renal disease that, in the opinion of the investigator, would impact the subject’s safety or the integrity of the study data.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •201 Currently receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of etelcalcetide. Other investigational procedures while participating in this study are excluded.
- •202 Subject previously has entered this study or previously exposed to etelcalcetide.
- •203 All herbal medicines (eg, St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of etelcalcetide, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of this review and Amgen acknowledgment is required for subject participation.
- •204 Use of any over-the-counter or prescription medications within the 14 days or
- •5 half-lives (whichever is longer) prior to receiving the first dose of etelcalcetide
- •that are not established therapies for subjects with renal disease or other
- •conditions secondary to renal disease will be reviewed by the Principal
- •Investigator and the Amgen Medical Monitor. Written documentation of this
- •review and Amgen acknowledgment is required for subject participation.
- •Paracetamol (up to 2 g per day) for analgesia will be allowed.
- •205 Malignancy except non-melanoma skin cancers,within the last 5 years.
- •206 History of hypersensitivity or allergic reaction to any of the excipients listed in
- •Section 6.2.1.
- •207 Subject received cinacalcet therapy within less than 30 days prior to etelcalcetide dosing.
- •208 A new onset of seizure or worsening of a pre-existing seizure disorder within
- •2 months prior to etelcalcetide administration.
- •209 Subject’s screening 12-lead ECG suggests unstable arrhythmia or other cardiac
- •abnormality that could place the subject at increased risk, based upon the
- •Investigator’s opinion.
- •210 History of prolongation of the QT interval (eg, congenital long QT interval,
- •second or third degree heart block or other conditions which prolong the QT
- •interval) or history of ventricular arrhythmias.
- •211 Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval (eg, sotalol, amiodarone, erythromycin, or clarithromycin). Please refer to the complete QT prolongation medication list at
- •http://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf
- •212 Subjects with a corrected QT Interval (QTc) > 500 ms during screening, using
- •Bazett’s formula.
- •213 Subject has a history of symptomatic ventricular dysrhythmias or Torsades de
- •214 Subject has a screening ALT or AST from the local lab = 1.5 times the upper limit of normal (ULN).
- •215 Female subjects of childbearing potential who are unwilling to practice true
- •sexual abstinence or use an acceptable method(s) of effective birth control
- •during treatment through 3 months after receiving the etelcalcetide.
- •216 Post-menarchal subject who is pregnant or breastfeeding, or is planning to
- •become pregnant or breastfeed during treatment and for an additional 3 months
- •after etelcalcetide administration. Female subjects with a positive pregnancy test
- •at screening.
- •217 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge.
研究者
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