Immune Thrombocytopenia Management in Adults

Immune Thrombocytopenia Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861297
• Other study ID #: NahdaV
• Status: Recruiting
• Phase: Phase 4
• Start date: May 5, 2020
• Est. completion date: April 2, 2024

Study information

• Verified date: May 2023
• Source: Nahda University
• Contact: Eman Mostafa Hamed, master
• Phone: 01019834193
• Email: eman.hamed[@]nub.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 467
• Est. completion date: April 2, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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
• 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.
• Rituximab
The third group received 500 mg/m2 intravenously of Rituximab once weekly for one month
• Eltrombopag
The fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months
• Romiplostim
The fifth group received 3µg/kg subcutaneous injection of Romiplostim once a week for 6 months

Locations

Country	Name	City	State
Egypt	EL-Kasr elineiy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nahda University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	18 months