EUCTR2008-005825-12-DE进行中（未招募）不适用
A Phase 3 Multicenter, Open-label, Switchover Trial to Assess the Safety and Efficacy of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients with Gaucher Disease Treated with Imiglucerase (Cerezyme®) Enzyme Replacement Therapy - NA
适应症
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
- •1. Males and females, 18 years or older
- •2. Female patients of child-bearing potential and male patients with female partners of child-bearing potential must agree to use two medically acceptable methods of contraception, one of which must be a barrier method, e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicidal and condom for at least 42 days after the treatment has finished.
- •3. Diagnosis of Gaucher disease with leukocyte GCD activity level =3 nmol/mg*hr (=30 % of the mean activity of the reference range)
- •4.Stable Gaucher disease, defined as:
- •a. Hemoglobin during Stability Evaluation Period is stable with no value more than 15% below or above the mean value
- •b. Platelets count during Stability Evaluation Period is stable with no values more than 40% below or above the mean value if the mean value is >120,000, or more than 20% below or above the mean value if the mean value is = 120,000
- •c. No major surgery in the last year
- •d. No blood transfusion or major bleeding episode in the last year
- •e. No acute avascular necrosis event in the last year
- •f. No evidence of spleen or liver increasing enlargement while being treated with enzyme replacement therapy by palpation, ultrasound, or MRI over the last year
- •5. Receiving imiglucerase therapy for at least 2 years and on a stable maintenance regimen (dose and regimen unchanged, except for situation of drug shortage) for at least last six months
- •6. Able to provide 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
- •1. Currently taking another experimental drug for any condition
- •2. Pregnant or nursing or planning to become pregnant
- •3. History of allergy to carrots
- •4. Presence of anti-glucocerebrosidase (GCD) antibodies
- •5. Previous infusion reaction suspected to be allergic in nature to Cerezyme® or Ceredase® or receiving premedication to prevent infusion reactions
- •6. Presence of HIV and/or HBsAg and/or hepatitis C infection
- •7. Presence of unresolved anemia due to iron, folic acid or vitamin B12 deficiency
- •8. Presence of any significant comorbidity that could confound the interpretation of the clinical response to prGCD
- •9. 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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