Biomodulin T Intramuscular for Thymus Hypoplasia in Children. Phase III

Phase 3

Recruiting

Conditions: Thymus hypoplasia
Thymic Hypoplasia
Thymus Gland /abnormalities

Registration Number: RPCEC00000247

Lead Sponsor: Center National of Bioproducts (BioCen)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Thymic Area (Ultrasound measurement of thymus in mm2). Measurement time: At baseline, 16 weeks and 32 weeks if you complete the third cycle.<br>2. Degree of thymic hypoplasia (Classification of degree of thymic hypoplasia according to scale in light, moderate or severe). Measurement time: At baseline, 16 weeks and 32 weeks if patient receives the third cycle.

Secondary Outcome Measures