EUCTR2014-005544-18-GB进行中（未招募）1 期
A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 24 Months to Adult Fabry Patients. - PB102F03: Extension Study of PRX-102 in Fabry Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
- •Eligible patients must fulfill the following inclusion criteria:
- •1.Completion of study PB-102-F02
- •2.The patient signs informed consent
- •3.Female patients and male patients whose co-partners are of child-bearing potential must agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used for 1 month after termination of treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •The presence of any of the following excludes a patient from study enrollment:
- •1.Pregnant or nursing
- •2.Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient’s compliance with the requirements of the study
研究者
相似试验
进行中（未招募）
1 期
Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 24 Months to Adult Fabry PatientsFabry diseaseMedDRA version: 18.0Level: PTClassification code 10016016Term: Fabry's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2014-005544-18-ESProtalix Ltd.15
已完成
1 期
Extension Study of PRX-102 for up to 60 MonthsFabry DiseaseNCT01981720Protalix15
进行中（未招募）
不适用
Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10Prophylaxis against invasive meningococcal diseaseEUCTR2014-004992-21-Outside-EU/EEAovartis Vaccines and Diagnostics S.r.l1,775
进行中（未招募）
不适用
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma.Revised Protocol 01, incorporating Amendment 02; and Pharmacogenetics Blood Sample Amendment #01, version 1.0 dated 01-Jul-05, Pharmacogenomics Archived Tissue Sample Amendment #03, version 1 dated 29-Mar-06 and Pharmacogenomic Biomarker Sample Amendment #04, version 1 dated 03-Apr-06.MelanomaEUCTR2005-002051-41-SEBristol-Myers Squibb International Corporation170
进行中（未招募）
不适用
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV MelanomaRevised Protocol 01, incorporating Amendment 02Estudio multicéntrico, fase II, de un solo brazo de tratamiento con MDX-010 (BMS734016) en monoterapia en pacientes con melanoma Estadio III o IV previamente tratadoMelanomaEUCTR2005-002051-41-ESBristol-Myers Squibb International Corporation170