The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP

NCT06913374 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DEX 2v3 in ITP
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.

Conditions

Thrombocytopenia

Keywords

ITP; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Sustained response

  Sustained response was defined as platelet count maintained above 30 × 10\^9/L with an absence of bleeding symptoms or no requirement for additional ITP treatment for six consecutive months following achievement of initial response. Complete response was defined as a platelet count of 100 × 10\^9 cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10\^9 cells per L or higher, but less than 100×10\^9 cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding.

  Month 6

Secondary Outcomes (6)

• Initial response

  Day 24

• Time to response

  24 days

• Duration of response

  12 months

• Bleeding scores

  12 months

• Health-related quality of life assessment

  12 weeks

Study Arms (2)

group DEX2

EXPERIMENTAL

In group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14).

Drug: Dexamethasone

group DEX3

EXPERIMENTAL

In group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24).

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

given orally at 40 mg per day for two cycles (days1-4, and days 11-14).

Also known as: DEX

group DEX2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be at least 18 years of age at the time of the screening.
• Participant may be male or female.
• Participant has a confirmed diagnosis of newly diagnosed ITP according to the 2019 International Working Group assessment at screening, and has a baseline platelet count of less than 30 × 10\^9 cells per L or had bleeding manifestations, or both.

You may not qualify if:

• Participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated H. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. Evan's syndrome.
• Participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin).
• Participant has a history of coagulopathy disorders other than ITP.
• Participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment.
• Participant has 12-lead ECG with changes considered to be clinically significant upon medical review at baseline.
• Participant has severe renal impairment (glomerular filtration rate less than 45ml/min/1.73 m2).
• Participant has 3 × upper limit of normal of any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
• Participant with any of the following conditions: severe immunodeficiency, active or previous malignancy, human immunodeficiency virus (HIV), hepatitis B or C virus infection, pregnancy or lactation.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital of Shandong university

Jinan, Shandong, 273300, China

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Ming Hou, Pro.

CONTACT

86-531-82169896; houming@medmail.com.cn

Yu Hou, Pro.

CONTACT

houyu2009@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: May 1, 2025
• Primary Completion: May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

CN (1)