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Immune Thrombocytopenia Management in Adults

Primary Purpose

Immune Thrombocytopenia Purpura

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
Prednisolone and Azathioprine
Rituximab
Eltrombopag
Romiplostim
Sponsored by
Nahda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia Purpura focused on measuring Primary Immune Thrombocytopenia, Etrombopag, Dexamethasone, Romiplostim, Rituximab, Autoimmune Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria were adult patients aged 18 years or older, diagnosed with primary ITP after excluding secondary causes and with an initial PLTs count of less than 30 ×109/L or with hemorrhage manifestations. Exclusion Criteria: 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.

Sites / Locations

  • EL-Kasr elineiyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Control group

PSL - AZA group

The RTX group

The ELTRO group

The ROMP group

Arm Description

The first (control )group includes patients with confirmed diagnosed who received IV pulse (High Dose-Dexamethasone) therapy

The second group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy

The third group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy

The fourth group includes patients with confirmed diagnosed who received E therapy

The fifth group includes patients with confirmed diagnosed who received Romiplostim therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

number of patients relapsed and adverse events
The secondary outcome measures were a number of patients relapsed and adverse events (AEs). Relapse was pointed out as PLTs count below 30×109/L or bleeding episodes owing to thrombocytopenia afterward achieving the CR

Full Information

First Posted
April 27, 2023
Last Updated
May 6, 2023
Sponsor
Nahda University
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1. Study Identification

Unique Protocol Identification Number
NCT05861297
Brief Title
Immune Thrombocytopenia Management in Adults
Official Title
The Outcomes and Safety of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients With Hemorrhage Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
January 18, 2024 (Anticipated)
Study Completion Date
April 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nahda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A prospective controlled randomized study was conducted on primary Immune thrombocytopenia patients. The study's main objective is to evaluate the efficacy and adverse events profile of the different therapeutic approaches during Immune thrombocytopenia. Upon the confirmation of the Immune thrombocytopenia diagnosis, all patients immediately initiated the High Dose-dexamethasone as a frontline therapy for Immune thrombocytopenia with a dose of 40 mg/m2 daily for 4 days/week in the first month for one cycle. Then, the recruited patients who fulfilled the inclusion criteria are randomly assigned into one of five groups. Among these patients, the control group received IV pulse (HD-DXM) therapy with 40 mg/m2 daily for 4 successive days in a 28-day cycle to complete the six cycles. The Prednisolone + Azathioprine 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 Rituximab group received 500 mg/m2 intravenously of Rituximab once weekly for one month. The Eltrombopag group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months. The Romiplostim group received 3μg/kg sub-cutaneous injection of Romiplostim once a week for 6 months. The first evaluation date of confirmed ITP diagnosis was well-defined as the first index date (baseline). After that, every patient visited the investigational site as the protocol prescribes once weekly to assess and adjust the doses of study medications. The outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia Purpura
Keywords
Primary Immune Thrombocytopenia, Etrombopag, Dexamethasone, Romiplostim, Rituximab, Autoimmune Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
comparsion between five groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
467 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The first (control )group includes patients with confirmed diagnosed who received IV pulse (High Dose-Dexamethasone) therapy
Arm Title
PSL - AZA group
Arm Type
Experimental
Arm Description
The second group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy
Arm Title
The RTX group
Arm Type
Experimental
Arm Description
The third group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy
Arm Title
The ELTRO group
Arm Type
Experimental
Arm Description
The fourth group includes patients with confirmed diagnosed who received E therapy
Arm Title
The ROMP group
Arm Type
Experimental
Arm Description
The fifth group includes patients with confirmed diagnosed who received Romiplostim therapy
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisolone and Azathioprine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
The third group received 500 mg/m2 intravenously of Rituximab once weekly for one month
Intervention Type
Drug
Intervention Name(s)
Eltrombopag
Intervention Description
The fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months
Intervention Type
Drug
Intervention Name(s)
Romiplostim
Intervention Description
The fifth group received 3μg/kg subcutaneous injection of Romiplostim once a week for 6 months
Primary Outcome Measure Information:
Title
total patients who achieved sustained and overall response
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
number of patients relapsed and adverse events
Description
The secondary outcome measures were a number of patients relapsed and adverse events (AEs). Relapse was pointed out as PLTs count below 30×109/L or bleeding episodes owing to thrombocytopenia afterward achieving the CR
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria were adult patients aged 18 years or older, diagnosed with primary ITP after excluding secondary causes and with an initial PLTs count of less than 30 ×109/L or with hemorrhage manifestations. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Mostafa Hamed, master
Phone
01019834193
Email
eman.hamed@nub.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Hamed
Phone
01286744337
Email
eman.hamed@nub.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Hussein Meabed, professor
Organizational Affiliation
faculty of medicine beni-suef university
Official's Role
Study Chair
Facility Information:
Facility Name
EL-Kasr elineiy
City
Cairo
ZIP/Postal Code
52611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doaa Mohamed El Demerdash
Phone
01003516382
Email
dr_eldemerdash@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed M. Khalaf
Phone
01204419172
Email
dr.ahmed201176@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Immune Thrombocytopenia Management in Adults

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