NL-OMON51992尚未招募2 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 (TIDAM). - Thymosin-a1 in immunodeficiency associated mood disorders
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Suffering from the following condition
- •Common 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).
- •Presence of a depressive mood disorder as determined by the Hamilton Rating
- •Scale for Depression (HAM-D) (above 12).
- •Age between 18 and 75.
- •In case of concomitant use of classical (tricyclic) or non-tricyclic
- •antidepressants (SSRI, SNRI, MAOI, other), with or without mood stabilizer: a
- •stable dosing regimen for a duration of at least 12 weeks prior to inclusion in
- •the clinical study
排除标准
- •- Active, concomitant autoimmune disease manifestations
- •- Renal insufficieny definied 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
- •becoming pregnant, unless they are using highly effective methods of
- •contraception
- •during dosing and for 2 days after last dose of study medication. Highly
- •contraception methods include:
- •- Total abstinence (when this is in line with the preferred and usual lifestyle
- •of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal,
- •postovulation methods) and withdrawal are not acceptable methods of
- •contraception.
- •- Female sterilization (have had surgical bilateral oophorectomy with or
- •without hysterectomy) or total hysterectomy or tubal ligation at least 6 weeks
- •before taking study treatment. In case of oophorectomy alone, only when the
- •reproductive status of the woman has been confirmed by follow up hormone level
- •assessment.
- •- Male sterilization (at least 6 months prior to screening). For female
- •patients on the study, the vasectomized male partner should be the sole partner
- •for that patient.
- •- Use of oral, injected or implanted hormonal methods of contraception or
- •placement of an intrauterine device (IUD) or intrauterine system (IUS) or other
- •forms of hormonal contraception that have comparable efficacy (failure rate
- •<1%), for example hormone vaginal ring or transdermal hormone contraception.,
- •In case of use of oral contraception women should have been stable on the same
- •pill for a minimum of 3 months before taking study treatment.
- •Women are considered post-menopausal and not in of child bearing potential if
- •they have had 12 months of natural (spontaneous) amenorrhea with an appropriate
- •clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have
- •had surgical bilateral oophorectomy (with or without hysterectomy), total
- •hysterectomy or tubal ligation at least six weeks ago. In the case of
- •oophorectomy alone, only when the reproductive status of the woman has been
- •confirmed by follow up hormone level
- •assessment she is considered not of child bearing potential., - History of
- •malignancy within the last 5 years, except for resected basal or squamous cell
- 另有 2 项未显示
研究者
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