Immune Thrombocytopenia Management in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

467 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2024-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombopoietin Agonists in Patients With Idiopathic Thrombocytopenic Purpura

NCT06137105

ITP - Immune Thrombocytopenia

NOT_YET_RECRUITING

High-dose Dexamethasone Plus Hetrombopag vs High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial

NCT05943691

ITP - Immune Thrombocytopenia

UNKNOWN PHASE2

A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP

NCT06658834

Primary Immune Thrombocytopenia

RECRUITING PHASE2

Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

NCT04588194

Immune Thrombocytopenia Thrombotic Thrombocytopenic Purpura

UNKNOWN PHASE2

Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial

NCT06992128

Primary Immune Thrombocytopenia (ITP)

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune Thrombocytopenia Purpura

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

comparsion between five groups

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

The fifth group received 3μg/kg subcutaneous injection of Romiplostim once a week for 6 months

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No