Immunomodulation With Eltrombopag in ITP

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Children's Hospital Basel; University Hospital, Basel, Switzerland
• Collaborators: Novartis Pharmaceuticals; Stiftung zur Förderung medizinischer und biologischer Forschung; University of Erlangen-Nürnberg, Department of Biology

Criteria

Inclusion Criteria:

• 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

• No previous treatment for ITP

• No steroids in the last 4 weeks (for other conditions)

• Bleeding severity and quality of life are neither an inclusion nor an exclusion criterion.

Exclusion Criteria:

• Patients previously treated for ITP (e.g. Steroid, intravenous immunoglobulin (IVIG), platelet infusion)

• Life-threatening bleeding (and inability to sign informed consent)

• Secondary ITP

• Positive family history for ITP

• Presence or history of autoimmune disease as judged by the investigator

• Hepatosplenomegaly in the clinical examination

• Relevant hepatic disease as judged by the investigator

• Presence or history of thromboembolic disease

• 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

• Any vaccination 2 weeks prior start of the study

• Immunsuppressive and antiplatelet drugs

• Known or suspected non-compliance, drug or alcohol abuse

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, incompetence to judge

• Participation in another study with investigational drug within the 30 days preceding and during the present study

• Enrolment of the investigator, his/her family members, employees and other dependent persons