Immune Thrombocytopenia Management in Adults

Nahda University

Status and phase: Enrolling; Phase 4

Conditions: Immune Thrombocytopenia Purpura

Treatments: Drug: Romiplostim; Drug: Rituximab; Drug: Prednisolone and Azathioprine; Drug: Dexamethasone; Drug: Eltrombopag

Study type: Interventional

Funder types: Other

Identifiers

NCT05861297

NahdaV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 467 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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467 participants in 5 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

PSL - AZA group

Experimental group

Description:

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

Treatment:

Drug: Prednisolone and Azathioprine

The RTX group

Experimental group

Description:

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

Treatment:

Drug: Rituximab

The ELTRO group

Experimental group

Description:

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

Treatment:

Drug: Eltrombopag

The ROMP group

Experimental group

Description:

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

Treatment:

Drug: Romiplostim