EUCTR2013-005098-28-EE进行中（未招募）1 期
A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
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
入选标准
- •A subject must meet all the following inclusion criteria to be eligible for participation in this
- •1. Male or female aged =18 years.
- •2. Subjects must be willing and able to provide written informed consent (if applicable, a legally authorized representative may provide informed consent on behalf of the subject).
- •3. Subjects who meet the clinical criteria for diagnosis of MG with an exacerbation defined as worsening of MG symptoms as defined by an MGFA classification IVb or V.
- •4. Subjects on long-term (8 weeks) corticosteroid treatment for MG.
- •5. Female subjects of child-bearing potential must have a negative test for pregnancy (human chorionic gonadotropin (HCG)-based assay).
- •6. Subjects must be willing to comply with all aspects of the clinical trial protocol, including blood sampling and long-term storage of extra samples, for the entire duration of the study.
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject meeting any of the following exclusion criteria is NOT eligible for participation in the study:
- •1. Subjects who have received immune globulin treatment given by IV, subcutaneous or intramuscular route within the last 30 days.
- •2. Subjects with documentation of a lack of clinical response to IVIG therapy for MG.
- •3. Subjects documented positive for antibodies directed against MuSK.
- •4. Subjects with CS treatment initiated within the last 8 weeks or modified within the last 2 weeks.
- •5. Subjects with PLEX within the last 30 days.
- •6. Subjects with MG exacerbation attributable to change in medication or evident infection as defined by, but not limited to, the presence of at least one of the following diagnostic features: 1) axillary temperature =38°C, 2) positive blood culture of infective microorganism, 3) white blood cell count >12×109/L and differential white blood cell count of >10% band neutrophils (>1.2×109/L), and 4) pulmonary infiltrate with consolidation on chest X-ray. Alternatively, other signs and symptoms may be considered for the diagnosis of evident infection according to the Investigator’s judgement.
- •7. Subjects with inadequate venous access.
- •8. Subjects with a history of anaphylactic reactions or severe reactions to any blood-derived product.
- •9. Subjects with a history of intolerance to any component of the investigational products (IPs).
- •10. Subjects with a documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past.
- •11. Subjects with a history of recent (within the last year) myocardial infarction, stroke or uncontrolled hypertension.
- •12. Subjects who suffer from uncontrolled congestive heart failure, embolism or documented electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation.
- •13. Subjects with current known hyperviscosity or hypercoagulable state.
- •14. Subjects currently receiving anti-coagulation therapy.
- •15. Subjects with a history of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Baseline Visit.
- •16. Subjects with active psychiatric illness that interferes with compliance or communication with health care personnel.
- •17. Females who are pregnant, breastfeeding, or of child-bearing potential, and unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study.
- •* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
- •18. Subjects with any medical condition which makes the clinical trial participation unadvisable or which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the clinical trial according to the Investigator’s judgment.
研究者
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