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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03244410
Other study ID # LCITP
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 7, 2017
Last updated August 7, 2017
Start date October 2017
Est. completion date January 2019

Study information

Verified date August 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number (cooper N et al 2006)

- recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( cooper N et al 2006) ( Gern Sheimer T 2009 )


Description:

Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is associated with the production of auto antibodies directed against platelet glycoprotein complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells ( Provan & Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et al 2006) ( Gern Sheimer T 2009)

There are many phases of the disease:

1. Newly diagnosed ITP : for all cases at diagnosis.

2. persistent ITP: for patients with ITP between 3 to 12 months.

3. chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).

- Although lymphocytopenia is a commonly reported feature of many chronic autoimmune disorders, differential white cell counts at presentation have seldom been evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed et al 2010)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date January 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Newly diagnosed cases of primary ITP , adults and children.

Exclusion Criteria:

- Cases of secondary ITP

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
complete blood picture
complete blood picture

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary lymphocyte count in immune thrombocytopenic purpura intital lymphocyte counts predictive value in immune thrombocytopenic purpura by complete blood picture 15 minutes
See also
  Status Clinical Trial Phase
Completed NCT00454857 - Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) N/A
Completed NCT01444417 - Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients Phase 3
Completed NCT00508820 - An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP Phase 3
Completed NCT00117143 - Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) Phase 1/Phase 2
Completed NCT00415532 - Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura Phase 3