EUCTR2012-001644-21-GB进行中（未招募）不适用
MEA115661: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in the MEA115588 or MEA115575 trials.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 651
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. Informed Consent: Prior to commencing any study related activities,
- •subjects must be able and willing to provide written informed consent.
- •2. MEA115588 or MEA11575 study completion: Completion of the double
- •blind investigational product treatment during MEA115588 or
- •3. Current Anti-Asthma Therapy: Asthma is currently being treated with
- •a controller medication (i.e., ICS or other asthma controlled medication)
- •and the subject has been on a controller therapy through the end of
- •MEA115588 or MEA115575. Subjects will be expected to continue
- •controller therapy for the duration of the study.
- •4. Male or eligible female subjects:
- •5. To be eligible for entry into the study, females of childbearing
- •potential must commit to consistent and correct use of an acceptable
- •method of birth control (Appendix 2) for the duration of the trial and for
- •4 months after the last study drug administration.
- •6. A serum pregnancy test is required of all females of childbearing
- •potential at the initial Baseline Visit (Visit 1). In addition, a urine
- •pregnancy test will be performed for all females of childbearing potential
- •prior to enrollment, during each scheduled study visit prior to the
- •injection of investigational product, and during the Follow-up Visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 522
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 113
排除标准
- •1. Hypersensitivity: Hypersensitivity reaction related to study medication
- •during the MEA115588 or MEA115575 that led to patient withdrawal.
- •Subjects who experienced a localized injection site reaction do not need
- •to be excluded.
- •2. Health Status: Clinically significant change in health status during
- •MEA115588 or MEA115575 which in the opinion of the investigator
- •would make the subject unsuitable for participation in this long-term
- •3. Malignancy: A current malignancy or malignancy that developed
- •during MEA115588 or MEA115575 (subjects that had localized carcinoma
- •of the skin which was resected for cure will not be excluded). [Note for
- •South Korea: Korean subjects with a diagnosis of malignancy within 5
- •years are excluded]
- •4. Prior SAE: A study related SAE in MEA115588 or MEA115575 that was
- •assessed as possibly related to study medication by the investigator.
- •5. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects
- •should not be enrolled if they plan to become pregnant during the time
- •of study participation.
- •6. ECG: Baseline ECG which has a clinically significant abnormality or
- •which shows QTcF =450msec or QTcF =480msec for subjects with
- •Bundle Branch Block.
- •7. Smoking status: Current smokers
研究者
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3 期
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