NCT06137105

Brief Summary

  1. 1.Assesement of response to Thrombopoietin receptor agonists (TPO-RAs) as treatment in Idiopathic thrombocytopenia purpura patients in Assiut University hospital.
  2. 2.Explore side effects of Thrombopoietin receptor agonists in Idiopathic thrombocytopenia purpura .
  3. 3.To study effect of thrombopoietin receptor agonists and Quality life in Idiopathic thrombocytopenia purpura patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2023

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

November 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 5, 2023

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of response to treatment will be clinical and laboratory assessment

    Platelet count should be measured weekly until a stable platelet count that is associated with an absence of bleeding symptoms is achieved for 4 weeks without adjustment and then measured monthly thereafter.

    Baseline

Study Arms (2)

Group 1

Group I : Romiplostim and Eltrombopag

Drug: eltrombopag and romiplastim

Group 2

Group II : recived corticosteroid.

Drug: eltrombopag and romiplastim

Interventions

Group I: eltrombopag and romiplastim Group II : recived corticosteroid.

Also known as: Corticosteroids
Group 1Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presented with Idiopathic thrombocytopenic purpura ( ITP) at clinical Hematology units, Internal Medicine Department at Assiut University . Patients above age of 18 years.

You may qualify if:

  • Patients presented with Idiopathic thrombocytopenic purpura (ITP)
  • patients above age of 18 years.

You may not qualify if:

  • patients below age of 18 years .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopagAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Study of Treatment with thrombopoietin agonists in patients with Idiopathic thrombocytopenic purpura

Study Record Dates

First Submitted

November 5, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 18, 2023

Record last verified: 2023-11