Immune Thrombocytopenia Management in Adults
The Outcomes and Safety of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients With Hemorrhage Comorbidity
1 other identifier
interventional
467
1 country
1
Brief Summary
Immune thrombocytopenia treatment has evolved recently. However, none of treatments have only benefits without drawbacks. This study compares the clinical outcomes and adverse drug patterns of different treatment options. Medications which will be assessed during the current study are High Dose-dexamethasone (HD-DXM) (control group), Prednisolone + Azathioprine, Rituximab, Eltrombopag, and Romiplostim.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2020
Longer than P75 for phase_4
1 active site
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
Study Start
First participant enrolled
May 5, 2020
CompletedFirst Submitted
Initial submission to the registry
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2024
CompletedMay 16, 2023
May 1, 2023
3.7 years
April 27, 2023
May 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total patients who achieved sustained and overall response
The primary outcomes were the total percentage of patients achieving a sustained response (SR) till the end of the study, complete response (CR), and partial response (PR). CR was characterized by the absence of bleeding and an increase in the platelet count to above 100×109/L after one month of the treatment. SR was defined as achieving CR or partial response (PR) until the end of the study with a 2-fold upsurge from starting point \[20, 21\]. PR was represented as PLTs count ≥ 30×109/L after one month following therapy, and no response (NR) was defined as platelets \< 30×109/L or bleeding
18 months
Secondary Outcomes (1)
number of patients relapsed and adverse events
18 months
Study Arms (5)
Control group
ACTIVE COMPARATORThe first (control )group includes patients with confirmed diagnosed who received IV pulse (High Dose-Dexamethasone) therapy
PSL - AZA group
EXPERIMENTALThe second group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy
The RTX group
EXPERIMENTALThe third group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy
The ELTRO group
EXPERIMENTALThe fourth group includes patients with confirmed diagnosed who received E therapy
The ROMP group
EXPERIMENTALThe fifth group includes patients with confirmed diagnosed who received Romiplostim therapy
Interventions
Patients were initiated with High Dose-Dexamethasone with a dose of 40 mg/m2 daily for four days per week immediately after the diagnosis of ITP for 6 months
the second group received 20 mg of Prednisolone three times daily and 1 mg/kg of oral Azathioprine once daily for two weeks, then tapering the Prednisolone dose through the subsequent weeks (6 weeks). While continuing treatment with Azathioprine for a total of six months.
The third group received 500 mg/m2 intravenously of Rituximab once weekly for one month
The fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months
The fifth group received 3μg/kg subcutaneous injection of Romiplostim once a week for 6 months
Eligibility Criteria
You may not qualify if:
- Patients with a confirmed secondary ITP diagnoses such as (chemicals induced, systemic lupus erythematosus, immune thyroid diseases, a lymphoproliferative disease, or chronic infection, such as Helicobacter pylori, human immunodeficiency virus (HIV) or hepatitis C virus (HCV); with cardiac, renal, or liver disease; who had received NSAIDs or anti-platelets within one month before the initiation of the enrollment were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nahda Universitylead
Study Sites (1)
EL-Kasr elineiy
Cairo, 52611, Egypt
Related Publications (1)
Hamed EM, Ibrahim ARN, Meabed MH, Khalaf AM, El Demerdash DM, Elgendy MO, Saeed H, Salem HF, Rabea H. Therapeutic Outcomes of High Dose-Dexamethasone versus Prednisolone + Azathioprine, Rituximab, Eltrombopag, and Romiplostim Strategies in Persistent, Chronic, Refractory, and Relapsed Immune Thrombocytopenia Patients. Pharmaceuticals (Basel). 2023 Aug 29;16(9):1215. doi: 10.3390/ph16091215.
PMID: 37765023DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohamed Hussein Meabed, professor
faculty of medicine beni-suef university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Assistant clinical pharmacy department, faculty of pharmacy
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 16, 2023
Study Start
May 5, 2020
Primary Completion
January 18, 2024
Study Completion
April 2, 2024
Last Updated
May 16, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share