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Immune Thrombocytopenia Management in Adults

NCT05861297 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2023-05-16

No results posted yet for this study

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.

Conditions

  • Immune Thrombocytopenia Purpura

Interventions

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

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.

DRUG

Rituximab

The third group received 500 mg/m2 intravenously of Rituximab once weekly for one month

DRUG

Eltrombopag

The fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months

DRUG

Romiplostim

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

Sponsors & Collaborators

  • Nahda University

    lead OTHER

Principal Investigators

  • Mohamed Hussein Meabed, professor · faculty of medicine beni-suef university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2024-01-18
Completion
2024-04-02

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05861297 on ClinicalTrials.gov