Immune Thrombocytopenia Management in Adults

Sponsor

Nahda University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05861297

Collaborator

(none)

467

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia Purpura	Drug: Dexamethasone Drug: Prednisolone and Azathioprine Drug: Rituximab Drug: Eltrombopag Drug: Romiplostim	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

467 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

comparsion between five groupscomparsion between five groups

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Outcomes and Safety of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients With Hemorrhage Comorbidity

Actual Study Start Date :

May 5, 2020

Anticipated Primary Completion Date :

Jan 18, 2024

Anticipated Study Completion Date :

Apr 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group The first (control )group includes patients with confirmed diagnosed who received IV pulse (High Dose-Dexamethasone) therapy	Drug: Dexamethasone 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
Experimental: PSL - AZA group The second group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy	Drug: Prednisolone and Azathioprine 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.
Experimental: The RTX group The third group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy	Drug: Rituximab The third group received 500 mg/m2 intravenously of Rituximab once weekly for one month
Experimental: The ELTRO group The fourth group includes patients with confirmed diagnosed who received E therapy	Drug: Eltrombopag The fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months
Experimental: The ROMP group The fifth group includes patients with confirmed diagnosed who received Romiplostim therapy	Drug: Romiplostim The fifth group received 3μg/kg subcutaneous injection of Romiplostim once a week for 6 months

Outcome Measures

Primary Outcome Measures

total patients who achieved sustained and overall response [18 months]
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 [18 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.