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CompletedPhase 2

Immunomodulation With Eltrombopag in ITP

Key facts

Who runs it
University Children's Hospital Basel
Where
Switzerland6 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
2 people enrolled
Started
1 Sept 2022
Ended
11 Apr 2024
Type of study
Interventional, 2 groups
Treatments tested
  • Eltrombopag (Revolade®)
  • standard therapy (without eltrombopag): HD-DXM
Record updated
15 October 2024

Who can take part

Age
18 years to 55 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Informed consent as documented by signature
  • Newly diagnosed primary ITP according to the definition of Rodeghiero et al. and a risk of platelet count of <30x109/l or risk of severe bleeding
  • First-line therapy maximum for 1 week prior to enrolment
  • Bleeding severity and quality of life are neither an inclusion nor an exclusion criterion

Who cannot take part

  • Patients treated with second-line drugs prior to enrolment
  • Any vaccination 2 weeks prior start of the study
  • Immunsuppressive and antiplatelet drugs
  • Known or suspected non-compliance, drug or alcohol abuse
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Life-threatening bleeding (and inability to sign informed consent)
  • Presence or history of autoimmune disease as judged by the investigator
  • Relevant hepatic disease as judged by the investigator
  • Presence or history of thromboembolic disease
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, incompetence to judge
  • Patients previously treated for ITP more than 7 days prior to enrolment (e.g. Steroid, intravenous immunoglobulin (IVIG), platelet infusion)
  • Secondary ITP
  • Positive family history for ITP
  • Hepatosplenomegaly in the clinical examination
  • Patients with splenectomy
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study
  • Lack of safe double contraception
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The study aims to investigate immunomodulatory effects of eltrombopag combined with dexamethasone in young and midlife adult patients with newly diagnosed primary Immune thrombocytopenia (ITP).

The 2 groups in the trial

  • Standard ArmOther group

    HD-DXM will be administered orally (40 mg) from day 1-4, followed by Arm 1: No planed further treatment. = standard therapy (without eltrombopag)

    Treatment: standard therapy (without eltrombopag): HD-DXM

  • Study ArmTreatment being tested

    HD-DXM will be administered orally (40 mg) from day 1-4, followed by Arm 2: The subjects in the experimental arm will be treated with eltrombopag: Eltrombopag (Revolade®), 50 mg PO, from day 5-140. Tapering over 1 week (week 21) from day 141-148 with 50 mg every second day. Eltrombopag will be administered on a starting dose of 50mg. After the end of treatment a clinical and laboratory observation follow-up period until week 30 follows.

    Treatment: Eltrombopag (Revolade®) and standard therapy (without eltrombopag): HD-DXM

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Immunomodulation in Young and Midlife Adults With Newly Diagnosed Primary Immune Thrombocytopenia (ITP): A Randomized Open Label Trial With High-dose Dexamethasone Versus Eltrombopag and High-dose Dexamethasone
Record updated
15 October 2024