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Immune Markers in Pediatric ITP on Second Line Therapy

NCT06093529 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2023-11-14

No results posted yet for this study

Summary

Immune thrombocytopenia (ITP) is a common autoimmune disease characterized by low platelet count and increased risk of bleeding. It affects approximately 50 to 100 cases per million people per year, with children accounting for half of the cases.

Conditions

  • ITP - Immune Thrombocytopenia

Interventions

DIAGNOSTIC_TEST

complete blood count, CD3+ , CD4+ , CD8+, CD16+, CD56+, IFN-γ.

1. Full history 2. Thorough clinical examinations 3. Laboratory investigations will include: 1. complete blood count with focus on platelet count, platelet distribution width and mean platelet volume. Platelet count will be confirmed by direct blood film and blood smear. 2. Measurements of CD3+, CD4+, CD8+ and natural killer cells (CD16+, CD56+) will be conducted using flow cytometry. 3. Serum IFN-γ levels will be determined using an ELISA kit. 4. Response to the treatment will be assessed according to The International Working Group criteria which defines Response as platelet count ≥ 30 x 10⁹/L and \>2-fold increase in platelet count from baseline and absence of bleeding, measured on 2 occasions greater than 7 days apart. No response is characterized by a platelet count \<30 x 10⁹/L or a less than 2-fold increase in platelet count from baseline, or the presence of bleeding.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Khaled I El-sayeh, M.D. · Assiut University

  • Mostafa M Embaby, M.D. · Assiut University

  • Azhar A Mohammed, M.D. · Assiut University

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-31
Completion
2025-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093529 on ClinicalTrials.gov