Thymosin-a1 in immunodeficiency associated mood disorders

Phase 1

• Conditions: Primary immunodeficiency; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-003327-15-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-19
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to establish in CVID patients with depression the changing, i.e. increasing, effect of Ta1 on the naïve CD4/CD8 ratio.;Secondary Objective: -Changes in depression, anxiety, fatigue and quality of life scores <br>-Changes in T lymphocyte subsets (such as Th1, Th2, Th17 and T regulatory cells) and T cell regulating cytokines (such as IL-7 and sCD25)<br>-Changes in levels of markers of inflammation, such as the hCRP and IL-6 serum levels and the monocyte inflammatory gene expression.<br>-Assessment of adverse events.<br>-Changes in antibiotic usage<br><br>;Primary end point(s): Primary endpoint of this study will be the increase in the naïve CD4+/CD8+ ratio, measured after 8 weeks of treatment and 8 weeks after termination of the treatment period (i.e. 16 weeks after initiation of treatment);Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated 8 weeks after start treatment and 8 weeks after termination of the treatment.