EUCTR2007-000498-42-ES进行中（未招募）不适用
Ensayo clinico de fase III, multicéntrico, aleatorizado, doble ciego; para evaluar la seguridad y eficacia de dos grupos paralelos de dosis de glucocerebrosidasa humana recombinante expresada en células vegetales (prGCD) en pacientes con enfermedad de Gaucher.A phase III Multicenter, Randomized, Double-Blind Trial to Assess the Safety and Efficacy of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients with Gaucher Disease. - NA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •-Males and females, 18 years or older.
- •-Female patients of child-bearing potential or male patients with female partners of child-bearing potential must agree to use two methods of contraception, one of wich must be a barrier method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms.
- •-Diagnosis of Gaucher disease with leukocyte GCD activity level =3 nmol/mg*hr (=30 % of the mean activity of the reference range)
- •-Splenomegaly defined as greater than eight times the expected volume [measured volume divided by estimated volume (0.2% of body weight)] as determined by MRI volumetric analysis
- •-Thrombocytopenia (defined as platelet counts <120,000 per mm3) with or without anemia (defined by hemoglobin at least 1 g/dL below normal range according to sex and age).
- •?Patients who have not received ERT in the past or patients who have not received ERT in the past 12 months and have a negative anti-glucocerebrosidase antibody
- •?Patients who have not received substrate reduction therapy (SRT) in the past 12 months.
- •?Ability to provide a written informed consent.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Currently taking another experimental drug for any condition
- •-Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease
- •-Previous anaphylactoid reaction to Cerezyme® or Ceredase®
- •-History of allergy to carrots
- •-Pregnant or nursing
- •-Presence of HIV and/or, HBsAg and/or hepatitis C infections
- •-Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient’s compliance with the requirements of the study.
研究者
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