PER-031-16尚未招募未知
A MULTICENTER, OPEN-LABEL, SAFETY EXTENSION STUDY WITH BENRALIZUMAB (MEDI-563) FOR ASTHMATIC ADULTS ON INHALED CORTICOSTEROID PLUS LONG-ACTING β2 AGONIST (MELTEMI)
ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2016年11月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1- Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
- •2- Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
- •3- Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of IP. Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD Intrauterine device/IUS Ievonorgestrel Intrauterine system, Depo-Provera™injections, oral contraceptive, and Nuvaring™. Women of childbearing potential (WOCBP) are defined as all females regardless of the onset of menarche who do not meet the definition below of women not of childbearing potential.
- •Women who are not of childbearing potential are defined as those who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of enrolment without an alternative medical cause. The following age-specific requirements apply:
- • Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and have follicle stimulating hormone (FSH) levels in the postmenopausal range
- • Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment
- •4- For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1
- •5- All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose
排除标准
- •1. Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric or major physical impairment that is not stable in the
- •opinion of the Investigator and could:
- •- Affect the safety of the patient throughout the study - Influence the findings of the study or their interpretations - Impede the patient’s ability to complete the entire duration of study
- •2. A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has
- •failed to respond to standard of care therapy
- •3. Any clinically significant change in physical examination, vital signs, ECG,
- •hematology, clinical chemistry, or urinalysis during the predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient’s ability to complete the entire duration of the study
- •4. Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been
- •treated/cured will not be excluded).
- •5. Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last
- •dose of the IP
- •6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1 7. Planned major surgical procedures during the conduct of the study 8. Previous participation in the present study 9. Concurrent enrolment in another drug-related interventional clinical trial 10. AstraZeneca staff involved in the planning and/or conduct of the study 11. Employees of the study center or any other individuals involved with the conduct of
- •the study or immediate family members of such individuals 12. Patients with important protocol deviations in the predecessor study at the
- •discretion of the Sponsor
- •13. Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved (see
- •Section 7.1.3.1)
研究者
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