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Clinical Trials/RPCEC00000247
RPCEC00000247
Recruiting
Phase 3

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 sites60 target enrollmentAugust 14, 2017
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ConditionsThymus hypoplasiaThymic HypoplasiaThymus Gland /abnormalities

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Thymus hypoplasia
Sponsor
Center National of Bioproducts (BioCen)
Enrollment
60
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 14, 2017
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Center National of Bioproducts (BioCen)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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