Recruiting PHASE4 Immune Thrombocytopenia

New treatment option for Immune Thrombocytopenia

Official title Short-course High-dose Prednisone and Dexamethasone in Children With ITP

ClinicalTrials.gov ID: NCT05522465

What this study is testing

What is Prednisone?

Prednisone is an investigational medicine, being studied as a potential treatment for immune thrombocytopenia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 29 to 14

You may be able to join if

  • people enrolled in this study must meet all of the following criteria:
  • Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
  • Age \> 28 days and ≤ 14 years old
  • Untreated PLT\<20×109/L, or PLT\<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
  • Have signed the informed consent

You likely can't join if

  • Anyone who has any of the following conditions will not enter the clinical study:
  • Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet...
  • Received glucocorticoid therapy within 6 months
  • Menstrual female children
  • Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
  • Patients who have received radiotherapy and chemotherapy
See the full eligibility criteria
Who can join
  • people enrolled in this study must meet all of the following criteria:
  • Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
  • Age \> 28 days and ≤ 14 years old
  • Untreated PLT\<20×109/L, or PLT\<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
  • Have signed the informed consent
What rules you out
  • Anyone who has any of the following conditions will not enter the clinical study:
  • Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and thrombopoietic drugs (recombinant human thrombopoietin...
  • Received glucocorticoid therapy within 6 months
  • Menstrual female children
  • Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
  • Patients who have received radiotherapy and chemotherapy
  • There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.)
  • There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results

The study team makes the final eligibility decision.

Where it's taking place

  • Fujian, Fujian, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 29 days to 14 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Fujian, Fujian, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.