PTI Fc: Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02821572
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 119
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a peripheral destruction of platelets responsible for bleedings.

Monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions.

Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa, FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous.

The aim of this study is to compare the expression of FcγR in patients with ITP on circulating monocytes and on splenic macrophages.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia	Biological: blood sample; Procedure: spleen sample

Study Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
• Actual Study Start Date: Oct 2, 2014
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
patient	Biological: blood sample; Procedure: spleen sample
control	Biological: blood sample; Procedure: spleen sample

Outcome Measures

Primary Outcome Measures

1. 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on monocytes will be compared between ITP patients at diagnosis and controls - physiological parameter [through study completion, an average of 2 years]

Secondary Outcome Measures

1. 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on splenic macrophages will be compared between ITP patients and controls. - physiological parameter [through study completion, an average of 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

ITP group

• Patients who have provided written consent

• Patients over 18 years

• Patients with national health insurance

• Patients with ITP, defined as thrombocytopenia < 100 G/L, after exclusion of infection- or drug-related thrombocytopenia and malignant hemopathy.

Control Group

• Persons who have provided a written consent

• Persons over 18 years

• Persons with national health insurance

• Persons without autoimmune disease

Exclusion Criteria:

• Patients under guardianship

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02821572
• Other Study ID Numbers: BONNOTTE PARI 2013
• First Posted: Jul 1, 2016
• Last Update Posted: Jun 21, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Jun 21, 2021