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).
- Conditions
- Inborn errors of immunityPrimary immunodeficiency10021460
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
- 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
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. Highly
effective
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
carcinoma of the skin, treated cervical dysplasia, or treated in situ cervical
cancer.
- Any psychological, familial, sociological or geographical cond
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint of this study will be the increase in absolute and relative<br /><br>numbers of peripheral blood T regulatory cells, measured after 8 weeks of<br /><br>treatment and 8 weeks after termination of the clinical study</p><br>
- Secondary Outcome Measures
Name Time Method