Evaluation of the efficacy and safety of Biomodulin T in pediatric patients with thymic hypoplasia associated or not with cellular immunodeficiency. Clinical Trial Phase III. Version 0.1.

Center National of Bioproducts (BioCen)0 个研究点目标入组 60 人开始时间: 2017年8月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment

•1. Patients with radiological confirmation by Thymus Ultrasound of Severe, Moderate or Light Thymic Hypoplasia with or without clinical manifestations of immunodeficiencies
•2. Both sexes between the ages of one and five years.
•3. That they are virgins of immunostimulating or immunosuppressive treatment, at least during the previous 6 months.
•4. Voluntariness of the patient's parent or guardian and giving written informed consent.

•1. Patients with a history of severe allergic reactions and / or severe generalized eczema.
•2. Patients with any other type of non-cellular immunodeficiency with exception of IgA partial deficiency.
•3. Di George Syndrome.
•4. Patients who have been treated with steroids in the previous 45 days.
•5. Patients with a diagnosis of tumor or autoimmune disease of any kind.
•6. Patients with chronic diseases of the type Diabetes Mellitus Type I or any other endocrinopathy.
•7. Patients with severe congenital malformations that cause disability or require medical or surgical treatment.
•8. Patients with hemoglobin lower than 9 g/L.

发起方

Center National of Bioproducts (BioCen)