NCT04482777

Brief Summary

To evaluate the role of IL37 in pathogenesis of ITP and to study the relation between IL37,Tlymphocytes,NK cells in ITP

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
3 years until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2 days

First QC Date

July 19, 2020

Last Update Submit

August 7, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • To decrease the immunity complications in ITP patients

    Early detection of immunity complications in ITP patients

    Baseline

  • To decrease case fatality rate

    Early detection of immunity complication will decrease mortality rate

    Baseline

Study Arms (3)

ITP

Patient newly diagnosied with ITP

Drug: Corticosteriod for treated patients

Treated

Patients with ITP recived treatment

Drug: Corticosteriod for treated patients

Control

Healthy people

Drug: Corticosteriod for treated patients

Interventions

Drug given to some patients with autoimmune disease

ControlITPTreated

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

To study initially enrolled 90 patients with ITP in Assiut hospital

You may qualify if:

  • Patients with ITP (moderate and sever) different age group.

You may not qualify if:

  • Patients with stroke and myocardial infarction,malignant tumors or pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.

    PMID: 28416506BACKGROUND
  • Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.

    PMID: 23714309BACKGROUND
  • Chen Z, Qu W, Wang HQ, Xing LM, Wu YH, Liu ZY, Zhang Y, Liu H, Dong XF, Tao JL, Shao ZH. [Relationship of Peripheral Blood IL-37 Expression with T Lymphocytes Subsets and NK Cells in Patients with Primary Immune Thrombocytopenia]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Aug;27(4):1201-1207. doi: 10.19746/j.cnki.issn.1009-2137.2019.04.034. Chinese.

    PMID: 31418380BACKGROUND
  • Zhao Y, Ni X, Xu P, Liu Q, Sun T, Liu X, Ji X, Qiu J, Li J, Wang S, Han P, Peng J, Hou M, Li G. Interleukin-37 reduces inflammation and impairs phagocytosis of platelets in immune thrombocytopenia (ITP). Cytokine. 2020 Jan;125:154853. doi: 10.1016/j.cyto.2019.154853. Epub 2019 Sep 23.

    PMID: 31557634BACKGROUND

Central Study Contacts

Marwa Mohamed

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 23, 2020

Study Start

July 30, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08