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