EUCTR2021-003327-15-NL进行中（未招募）1 期
An open-label, 8-week, proof of concept trial on thymosin-a1 (thymalfasin) in the treatment of primary antibody deficiency (PAD) associated mood disorders (TIDAM18). - TIDAM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 20
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
- •-Written informed consent must be obtained before any assessment is performed.Suffering from the following condition
- •oCommon variable immunodeficiency (CVID), with an established diagnosis according to the diagnostic criteria from the European Society for Immunodeficiences (ESID) 2014, in accordance with the International Union of Immunological Societies (IUIS).
- •-Stable and standard use of classical (tricyclic) or non-tricyclic antidepressant (SSRI, SNRI, MAOI, other), with or without mood stabilizer, in a stable dosing regimen for a duration of at least 4 weeks prior to inclusion in the clinical study
- •-Presence of a depressive mood disorder as determined by the Hamilton Rating Scale for Depression (HAM-D) (above 12).
- •-Age between 18 and 75.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •-Active, concomitant autoimmune disease clinical manifestations
- •-Renal insufficiency defined by a creatinine clearance of less than 30 ml/min (CKD-EPI or MDRD formula)
- •-Hepatic impairment, i.e. unexplained persistent liver function abnormalities
- •-Laboratory parameters at the pre-treatment visit showing any of the following abnormal results: transaminases > 2x the upper limit of normal (ULN) and/or bilirubin > 2x ULN
- •-Severe cardiac (LVEF < 45%) and/or pulmonary disease (FVC <50%)
- •-History of heart failure, symptomatic coronary artery disease, significant ventricular tachyarrhythmia, stent placement, coronary artery bypass surgery, and/or myocardial infarction
- •-Use of other investigational drugs, within 5 half-lives of enrollment or within 30 days, whichever is longer
- •-History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
- •-Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- •-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 days after last dose of study medication.
- •-History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma of the skin, treated cervical dysplasia, or treated in situ cervical cancer.
- •-Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •-Any condition or treatment, which in the opinion of the investigator, places the subject at unacceptable risk as a patient in the trial.
研究者
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