EUCTR2005-000343-28-IT进行中（未招募）不适用
An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND
ASPREVA PHARMACEUTICALS CORPORATIO0 个研究点目标入组 136 人开始时间: 2006年3月15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
- 136
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
- •Subjects who 1. Provide written informed consent for this optional double-blind treatment continuation study. 2. Have completed 36 weeks of treatment with double-blind MMF or placebo in Protocol WX17798 3. Have achieved good symptom control with a stable prednisone dose. Good symptom control is defined as Minimal Manifestations or Pharmacologic Remission MGFA Postintervention Status definitions modified from Week 32 until study termination at Week 36 of Protocol WX17798. Stable prednisone dose is defined as no change in the prednisone dose required after Week 32
- •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. Pregnancy, breastfeeding, or lactation, or use of a non-reliable method of contraception 2. Receiving or requiring regularly scheduled plasma exchange PE or intravenous immunoglobulin IVIG treatment 3. Participation in another clinical trial and/or receipt of investigational drugs during the double-blind continuation 4. Use of other prohibited medications 5. Medical condition, adverse event or intolerance of double-blind treatment that would preclude continuation, including - thymoma - severe active gastrointestinal disease; persistent severe diarrhea; gastrointestinal hemorrhage - active unhealed peptic ulcer - congenital or acquired immunodeficiency - clinically significant drug or alcohol abuse - malignancy or lymphoproliferative disease - serious bacterial infection requiring IV antibiotic treatment , serious viral infection e.g. organ-invasive viral disease including H. simplex, H. zoster, and cyclomegalovirus , or invasive fungal disease during Protocol WX17798 - - - - - - - - - uncontrolled thyroid disease - severe cardiovascular disease - uncontrolled persistent hypertension - uncontrolled diabetes mellitus - significant kidney dysfunction or liver dysfunction serum creatinine 200 mol/L; aspartate transaminase AST , alanine aminotransferase ALT , or bilirubin greater than 2.5 times the upper limit of normal - pulmonary insufficiency requiring supplemental oxygen - bone marrow insufficiency; hemoglobin 9 g/dL; leucopenia white blood cell count WBC 3000/mm3; absolute neutrophil count ANC 1.5/ L ; thrombocytopenia platelet count 100,000/mm3 6. Other medical condition which in the investigator s judgment may be associated with increased risk to the subject.
研究者
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