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Study comparing dexamethasone versus immunoglobulin plus prednisone for adults with immune thrombocytopenia (ITP) who have moderate to severe bleeding

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on adults with Immune Thrombocytopenia (ITP), a condition where the immune system attacks blood platelets, leading to bleeding problems. The research compares two different treatment approaches for patients experiencing mild to severe bleeding symptoms. The purpose is to determine if one treatment method works as effectively as the other.

The first treatment combination consists of intravenous immunoglobulin given through a vein along with oral prednisone tablets taken daily for three weeks. The second treatment option involves high-dose dexamethasone tablets taken for four days. Both treatments aim to increase the number of platelets in the blood and reduce bleeding symptoms.

The study will track how quickly patients respond to treatment over the first five days, particularly looking at improvements in platelet counts and reduction in bleeding. Patients will be monitored for six months to evaluate the long-term effectiveness of both treatments. Throughout the study, doctors will regularly check platelet counts and assess any bleeding symptoms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment - Group 1

    If assigned to the first treatment group, you will receive intravenous immunoglobulin (IVIg) at 1g/kg on days 1 and 2, combined with prednisone tablets at 1 mg/kg daily for 3 weeks

    The medication will be given through an intravenous line (directly into your vein) in a medical setting

  2. Step 2

    Initial treatment - Group 2

    If assigned to the second treatment group, you will receive dexamethasone tablets at 40 mg daily on days 1 through 4

    The medication will be taken by mouth according to the prescribed schedule

  3. Step 3

    Initial monitoring period

    Your blood platelet count will be monitored during the first 5 days of treatment

    Medical staff will check for any signs of bleeding

    Your response to treatment will be evaluated based on your platelet count reaching 30,000 or higher per microliter of blood

  4. Step 4

    Follow-up period - First month

    Your condition will be monitored for 28 days after starting treatment

    Medical staff will track any bleeding episodes

    Blood tests will be performed to check your platelet count

  5. Step 5

    Long-term follow-up

    Your condition will be monitored for a total of 6 months

    Regular blood tests will continue to check your platelet count

    Any side effects or bleeding episodes will be recorded

Who can join the trial?

7 criteria

  • Must be between 18 and 80 years old
  • Must have been diagnosed with immune thrombocytopenia (ITP) - a condition where the immune system attacks blood platelets, either newly diagnosed or recurring
  • Must have a platelet count equal to or below 20 x 109/L (platelets are blood cells that help with blood clotting)
  • Must have visible signs of bleeding, either:
    • on the skin (cutaneous bleeding), and/or
    • on mucous membranes (such as inside mouth, nose, or other body cavities)
    • Must be registered with a social security system
    • Must be able and willing to provide written informed consent to participate in the study

Who cannot join the trial?

14 criteria

  • Patients under 18 years old (minors)
  • Patients with active or chronic infections (ongoing illnesses caused by bacteria, viruses, or other microorganisms)
  • Those with uncontrolled high blood pressure (hypertension)
  • Patients with active peptic ulcers (open sores in stomach or small intestine)
  • People with uncontrolled diabetes (unstable blood sugar levels)
  • Patients with known hypersensitivity (allergic reactions) to dexamethasone, prednisone, or IVIg
  • Pregnant or breastfeeding women
  • Patients with severe liver disease (conditions affecting liver function)
  • Those with severe kidney disease (conditions affecting kidney function)
  • Patients with active malignancy (cancer currently requiring treatment)
  • Those participating in other clinical trials
  • Patients unable to provide informed consent
  • Individuals with history of blood clotting disorders
  • Those with severe cardiovascular disease (serious heart conditions)
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Investigated drugs

  • Intravenous Immunoglobulin (IVIg)

    is a medication made from donated blood plasma that contains antibodies. It helps boost the immune system and is commonly used to treat immune disorders. In this trial, it's used to help increase platelet counts in patients with immune thrombocytopenia (ITP), a condition where the body's immune system attacks its own platelets.

  • Prednisone

    is an oral steroid medication that helps reduce inflammation and suppress the immune system. It's commonly used to treat various autoimmune conditions, including ITP, by preventing the immune system from destroying platelets.

  • Dexamethasone

    is a potent steroid medication that, like prednisone, works to suppress the immune system and reduce inflammation. It's often used as an alternative to prednisone in treating ITP and other autoimmune conditions. This medication is typically taken orally and can help increase platelet counts by preventing the immune system from attacking platelets.

What is already known about the treatment

  • Intravenous Immunoglobulin (IVIg)

    A blood product administered intravenously that contains pooled antibodies from multiple donors, used in the treatment of immune thrombocytopenia (ITP). It works by blocking the destruction of platelets by the immune system and helps to rapidly increase platelet counts in patients with bleeding manifestations. This medication belongs to the class of immune globulin therapies and is typically administered over several hours under medical supervision.

  • Prednisone

    An oral corticosteroid medication that suppresses the immune system and reduces inflammation, commonly used in treating immune thrombocytopenia (ITP). It works by decreasing the activity of the immune system that is destroying platelets, thereby helping to increase platelet counts and reduce bleeding risk. This medication belongs to the glucocorticoid class and is typically taken daily as prescribed.

  • Dexamethasone

    A potent oral corticosteroid medication that provides strong anti-inflammatory and immunosuppressive effects in the treatment of immune thrombocytopenia (ITP). It works similarly to prednisone but is more potent and is typically given in high doses for a shorter duration (four days). This medication belongs to the glucocorticoid class and is often preferred for its shorter treatment course and potentially fewer long-term side effects.

Investigated diseases

Immune Thrombocytopenia (ITP) - A blood disorder where the immune system mistakenly attacks and destroys platelets, which are blood cells needed for normal blood clotting. The condition causes lower than normal platelet counts in the blood, which can result in easy bruising and bleeding. ITP can develop suddenly or gradually, and it may occur after a viral infection or other triggering event. The severity of symptoms can vary among individuals, with some experiencing mild bruising while others may have more noticeable bleeding manifestations. In adults, ITP often becomes a chronic condition that can persist for months or years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516403-16-00Protocol codeAPHP200017Estimated enrolment272 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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