EUCTR2013-005099-17-DE进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis
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
- 60
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
- •1. Male or female ages 18 to 85 years
- •2. Anti-AChR antibody positive
- •3. Confirmed diagnosis of generalized MG historically meeting the clinical criteria for diagnosis of MG defined by the MGFA classification of Class II, III, IV, or V historically (Appendix 2).
- •4. At Screening, subjects may have symptoms controlled by CS (for example, only ocular [Class I] symptoms may be evident or there may be no symptoms) or be MGFA Class II-IVa inclusive (Class IVb and Class V excluded). Note: Subjects who only have a history of ocular MG may not enroll.
- •5. On systemic CS for a minimum period of at least three months and on a stable CS dose of =15 mg/day and =60 mg/day (prednisone equivalent) for the month prior to Screening. Individuals on alternate day CS dosing will be judged to be on a daily dose equivalent to half their alternate day dose (i.e., 40 mg/every other day = 20 mg/day).
- •6. The investigator feels that tapering the CS dose is currently appropriate (to be commenced as prescribed during this protocol)
- •7. At least one previous completed attempt to taper CS in order to minimize CS dose
- •8. Subjects must be willing and able to provide written informed consent.
- •9. Subjects must be willing to comply with all aspects of the clinical trial protocol.
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Any dose change in concomitant immunosuppressant therapy, other than CS, in the prior six months
- •2. Any change in CS dose or acetylcholinesterase inhibitor (e.g., pyridostigmine) dose in the one month prior to Screening
- •3. A three-point change in QMG score, increased or decreased, between the Screening/Week -3 (Visit 0) and Baseline (Week 0 [Visit 1])
- •4. Any episode of MC in the one month prior to Screening or (at any time in the past) MC or hospitalization for MG exacerbation associated with a previous CS taper attempt
- •5. Evidence of malignancy within the past 5 years (non-melanoma skin
- •cancer, carcinoma in situ of cervix is allowed) or thymoma potentially requiring surgical intervention during the course of the trial (intent to
- •perform thymectomy)
- •6. Thymectomy within the preceding six months prior to Screening
- •7. Rituximab, belimumab, eculizumab or any monoclonal antibody used for
- •immunomodulation within the past 12 months prior to Screening
- •8. History of non-response to IVIg when used in maintenance therapy of the subject’s MG, as judged by the investigator
- •9. Have received immune globulin treatment given by IV, subcutaneous, or intramuscular route within the last 3 months prior to Screening
- •10. Received plasma exchange (PLEX) performed within the last 3 months prior to Screening
- •11. Inadequate venous access
- •12. History of anaphylactic reactions or severe reactions to any blood-derived product
- •13. History of intolerance to any component of the IPs
- •14. Documented diagnosis of thrombotic complications to polyclonal IVIg therapy in the past
- •15. History of recent (within the last year) myocardial infarction or stroke
- •16. Uncontrolled congestive heart failure; embolism; or historically documented (within the last year) electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation
- •17. Current known hyperviscosity or hypercoagulable state
- •18. Currently receiving anti-coagulation therapy (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], parenteral anticoagulants [e.g., fondaparinux]). Note that oral anti-platelet agents are allowed (e.g., aspirin, clopidogrel, ticlodipine)
- •19. History of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Screening/Week -3 (Visit 0)
- •20. Active psychiatric illness that interferes with compliance or communication with health care personnel
- •21. Females of child-bearing potential who are pregnant, have a positive serum pregnancy test (human chorionic gonadotropin [HCG]-based assay), breastfeeding, or are 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 th
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