EUCTR2009-014669-13-GB进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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. Male or female patient =18 – =80 years old.
- •2. Generalized MG with prominent clinical symptoms.
- •3. Diagnosis of MG must be made by the tests described in the protocol (section 8.1).
- •4. MGFA Clinical Classification Class II, III or IVa.
- •QMG for Disease Severity total score =12.
- •6. Minimum score of two (2) in four (4) or more test items in the QMG.
- •7. Able to give informed consent.
- •8. Able and willing to comply with study procedures.
- •9. Sexually active women of childbearing potential must be practicing an effective, reliable and medically acceptable contraceptive regimen during the entire duration of the study and for 5 months after taking the last dose of study drug
- •10. Patients shall have failed treatment or have not achieved significant clinical benefit with at least two immunomodulators
- •11. If patients enter the study taking azathioprine (AZA) they must have been on AZA for =12 months and have been on a stable dose for =2 months prior to screening.
- •12. If patients enter the study taking other immunosuppressive treatments, they must have been on treatment for =6 months and have been on a stable dose for =2
- •months prior to screening.
- •13. Patients who enter the study taking oral corticosteroids must have been on a stable dose for =4 weeks (28 days) prior to screening.
- •14. Patients who enter the study taking a cholinesterase inhibitor must have been on a stable dose for =2 weeks prior to screening.
- •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. History of thymoma or other neoplasms of the thymus.
- •2. History of thymectomy within 12 months prior to screening.
- •3. MG status which in the opinion of the Investigator is unstable or with fixed weakness (i.e. burned-out”) such that the patient is unlikely to respond to therapy based on the patient’s disease severity, pace of progression and prior MG treatment history.
- •4. Pregnancy or lactation.
- •5. Active infections at screening.
- •6. Current chronic use of plasmapheresis/plasma exchange defined as requiring plasma
- •exchange on a regular basis for the management of muscle weakness two or more times
- •in one year, or any plasma exchange within 3 months prior to screening.
- •7. IVIG treatment within 8 weeks prior to screening.
- •8. Use of etanercept (TNF inhibitor, Enbrel®) within 2 months prior to screening.
- •9. Use of rituximab (RITUXAN®) within 6 months prior to screening.
- •10. Severe weakness predominantly affecting oropharyngeal or respiratory muscles or both
- •(MGFA Class IVb).
- •11. Crisis or impending crisis as evidenced by forced vital capacity (FVC) <10mL/Kg or
- •<35% of predicted value, or bulbar weakness severe enough to compromise airway
- •protection at screening.
- •12. Need or use of intubation, with or without mechanical ventilation, except when employed during routine postoperative management at screening (MGFA Clinical Classification V).
- •13. Weakness only affecting ocular or peri-ocular muscles (MGFA Class I).
- •14. History of splenectomy.
- •15. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days prior to screening.
- •16. History of meningococcal disease.
- •17. Known or suspected complement deficiency.
- •18. Patients who are not vaccinated against N. meningitidis at least 14 days prior to Visit 2.
- •19. Any medical or psychological condition that, in the opinion of the investigator, could increase the patient’s risk by participating in the study or confound the outcome of the study.
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to evaluate the effects of JZP-110 (study drug) on driving performance in subjects with excessive sleepiness due to Obstructive Sleep ApneaTreatment of excessive sleepiness in adult patients with obstructive sleep apneato increase the ability to stay awake throughout the day.MedDRA version: 20.0Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndromeSystem Organ Class: 100000004855EUCTR2015-003930-28-DEJazz Pharmaceuticals Inc.34
进行中（未招募）
1 期
A study designed to evaluate the effects of BMS-986231 versus placebo on urine output when taken with a single dose of a diuretic (furosemide). BMS-986231 or Placebo are provided in the form of Intravenous Infusions for a duration of 8 hours, with furosemide given after 4 hours, in patients whose heart is unable to pump sufficiently (chronic heart failure); exposed to each of the 2 interventions over the course of the study.EUCTR2018-000970-31-GBBristol-Myers Squibb International Corporation20
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the beta3-Adrenergic Receptor Agonist Solabegron in Subjects with Irritable Bowel Syndrome - N/AIrritable Bowel Syndrome (IBS)EUCTR2005-006118-17-DEGlaxoSmithKline Research and Development Limited100
已完成
4 期
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of NSAID for the control of Acid-Induced Heartburn Symptom in Healthy VolunteersGastroesophageal Reflux Disease (GERD)JPRN-UMIN000014595Hyogo College of Medicine12
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI)MedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersEUCTR2008-000061-37-ITEURAND SPA72