Role of CD11a in Pathogenesis of Primary ITP and Effect of Immunosuppressive Therapy on Its Level

NCT03864796 | Completed

• 1 other identifier: CD11a in ITP
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The purpose of this study is to investigate the expression of CD11a on subpopulation of lymphocytes and compared its expression between ITP patients and healthy controls and explores its possible role in the pathogenesis of ITP.
2. 2.this may help in decision to use inhibitors (have been developed to block ICAM-1/LFA-1 interactions,) as a line of treatment for ITP and some of these molecules have reached clinical trials.
3. 3.to study if there is correlation between level of CD11a and severity of bleeding at presentation (estimated by bleeding score defined by British Journal of Haematology 2007 and platelet count)
4. 4.to study effect of immunosuppressive treatment on the level of CD11a by evaluating levels of CD11a after response to treatment.

Conditions

Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (2)

• detection of possible role of CD11a in pathogenesis of ITP

  assaying of CD11a in patients and healthy individual

  1 year

• detection of effect of immunosuppressive therapy on the level of CD11a in patients of ITP

  to study effect of immunosuppressive treatment on the level of CD11a by evaluating levels of CD11a after response to treatment.to detect possible role of CD11a-ICAM1 blocker in treatment of ITP

  1 year

Study Arms (3)

cases of newly diagnosed ITP

no intervention

cases of ITP after responding to treatment

no intervention

healthy subjects

no intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

people with newely diagnosed primary ITP and healthy control

You may qualify if:

• newly diagnosed primary immune thrombocytopenic patients

You may not qualify if:

• We will exclude patients with any other possible cause of thrombocytopenia either immune or non immune as:
• Patients with diabetes
• HCV
• other autoimmune disease (as SLE or RA)
• Chronic Liver or kidney disease

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Mona

Asyut, Egypt

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Howwaida AH Nafady, Prof.

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical research

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 6, 2019
• Study Start: March 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: January 1, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

EG (1)