NL-OMON34074招募中3 期
A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis - RP103-03
Raptor Pharmaceuticals Europe BV0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •Male or female subject with a documented diagnosis of nephropathic cystinosis.
- •Subject must be on a stable dose of Cystagon® sufficient to maintain their white blood cell (WBC) cystine level at <= 1.0 nmol/half-cystine/mg protein.
- •Subject must be able to swallow their typically administered Cystagon® capsule with the capsule intact.
- •Within the last 6 months, no clinically significant change from normal in liver function tests [i.e., 1.5 times ULN for ALT and AST, and/or 1.5 times ULN for total bilirubin] and renal function
- •[i.e., estimated GFR (corrected for body surface area)] at Screening as determined by the Investigator.
- •Subject must have an estimated GFR (corrected for body surface area) > 30 mL/minute/1.73 m2.
- •Sexually active female subjects of childbearing potential (i.e., not surgically sterile [tubal ligation, hysterectomy, or bilateral oophorectomy] or at least 2 years naturally postmenopausal)
- •must agree to utilize the same acceptable form of contraception from Screening through completion of the study. The acceptable forms of contraception for this study include hormonal
- •contraceptives (oral, implant, transdermal patch, or injection) at a stable dose for at least 3 months prior to Screening, barrier (spermicidal condom, diaphragm with spermicide), IUD, or a
- •partner who has been vasectomized for at least 6 months. For pre-pubescent children, a documented attestation of abstinence from their parent or guardian will be acceptable.
- •Subject must be willing and able to comply with the study restrictions and requirements.
- •Subject or their parent or guardian must provide written informed consent and assent (where applicable) prior to participation in the study.
排除标准
- •Subject*s age < 6 years old or subjects weight < 21 kg.
- •Subjects with current history of the following conditions or any other health issues that make it, in the opinion of the Investigator, unsafe for them to participate:
- •- Inflammatory bowel disease (if currently active) or prior resection of small intestine;
- •- Heart disease (e.g., myocardial infarction, heart failure, unstable arrhythmias, or poorly controlled hypertension) 90 days prior to Screening;
- •- Active bleeding disorder 90 days prior to Screening;
- •- History of malignant disease within the last 2 years.
- •Subject with a hemoglobin level of < 10 g/dL at Screening or, in the opinion of the Investigator, a hemoglobin level that would make it unsafe for the subject to participate.
- •Subjects receiving any form of cysteamine medication through a gastric tube.
- •Subjects who are receiving maintenance dialysis or who have had a kidney transplant.
- •Subjects who are on an active kidney transplant list or who are planning to receive a kidney transplant within 3 months of Screening.
- •Subjects with known hypersensitivity to cysteamine and penicillamine.
- •Female subjects who are nursing, planning a pregnancy, known or suspected to be pregnant, or with a positive serum pregnancy screen.
- •Subjects who have a made a blood donation within 30 days of Screening.
- •Subjects who, in the opinion of the Investigator, are not able or willing to comply with the protocol.
研究者
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