Status:
COMPLETED
Immunomodulation With Eltrombopag in ITP
Lead Sponsor:
University Children's Hospital Basel
Collaborating Sponsors:
Stiftung zur Förderung medizinischer und biologischer Forschung
Novartis Pharmaceuticals
Conditions:
Primary Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
The randomized open lable study aims to investigate immunomodulatory effects of eltrombopag combined with dexamethasone in young and midlife adult patients with newly diagnosed primary ITP. Treatment ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients previously treated for ITP more than 7 days prior to enrolment (e.g. Steroid, intravenous immunoglobulin (IVIG), platelet infusion)
- Patients treated with second-line drugs prior to enrolment
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04812483
Start Date
September 1 2022
End Date
April 11 2024
Last Update
October 15 2024
Active Locations (6)
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1
Aarau Cantonal Hospital, Division of Hematology
Aarau, Switzerland
2
University Children's Hospital Basel (UKBB)
Basel, Switzerland, 4031
3
University Hospital Basel, Division of Hematology
Basel, Switzerland, 4031
4
University Hospital Bern, Division of Hematology
Bern, Switzerland