EUCTR2009-017882-42-NL进行中（未招募）不适用
A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic Cystinosis
Raptor Therapeutics Inc.0 个研究点目标入组 20 人开始时间: 2010年6月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 or female subject with a documented diagnosis of
- •nephropathic cystinosis.
- •2. 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.
- •3. Subject must be able to swallow their typically administered
- •Cystagon® capsule with the capsule intact.
- •4. 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.
- •5. Subject must have an estimated GFR (corrected for body surface
- •area) > 30 mL/minute/1.73 m2.
- •6. 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.
- •7. Subject must be willing and able to comply with the study
- •restrictions and requirements.
- •8. Subject or their parent or guardian must provide written informed
- •consent and assent (where applicable) prior to participation in the
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •1. Subject’s age < 6 years old or subjects weight < 21 kg.
- •2. 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.
- •3. 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.
- •4. Subjects receiving any form of cysteamine medication through a
- •gastric tube.
- •5. Subjects who are receiving maintenance dialysis or who have
- •had a kidney transplant.
- •6. Subjects who are on an active kidney transplant list or who are
- •planning to receive a kidney transplant within 3 months of
- •7. Subjects with known hypersensitivity to cysteamine and
- •penicillamine.
- •8. Female subjects who are nursing, planning a pregnancy, known
- •or suspected to be pregnant, or with a positive serum pregnancy
- •9. Subjects who have a made a blood donation within 30 days of
- •10. Subjects who, in the opinion of the Investigator, are not able or
- •willing to comply with the protocol.
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