Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812483
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2021-03-01
Brief Title:
Immunomodulation With Eltrombopag in ITP
Sponsor:
University Childrens Hospital Basel
Organization:
University Childrens Hospital Basel
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iROM2
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 protocol will be HD-DXM 40 mg PO day 1-4 with or without eltrombopag 25-50 mg PO day 5-140 on an outpatient basis Immunological investigations will be performed before start of treatment and then on week 3 20 end of therapy and 30
1 Intervention phase
Medical history and physical examination including assessment of severe bleeding every week until week 4 every second week until week 20 Complete blood count every week until week 10 For the adjustment of the Thrombopoietin receptor agonist TPO-RA dose - every second week until week 20 Immunologic panel at the beginning and at week 3 and 20
2 Follow-up
Three clinical visits are scheduled in the follow-up including a complete blood count at week 22 24 and 30 Immunologic panel will be done at week 30 end of study
High-dose dexamethasone HD-DXM will be administered orally 40 mg from day 1-4 followed by Arm 1 or 2 11 randomization
Arm 1 Standard Arm No planed further treatment standard therapy In case of non-response after 2 courses of HD-DXM week 4 cross-over to Arm 2 Start Eltrombopag Revolade 50 mg PO until day 140 details see Arm 2
In case of relapse repeat HD-DXM 40 mg day 1-4 up to a maximal of 3 courses Time between 2 courses should be minimal 14 days In case of re-relapse after the third course cross-over to Arm 2 Start Eltrombopag Revolade 50 mg PO until day 140 details see Arm 2
Arm 2 Study Arm Eltrombopag Revolade 50 mg per os from day 5-140 Tapering over 1 week from day 141-148 with 50 mg every second day
In case of non-response after 4 weeks on eltrombopag drop out
1 Intervention phase
Medical history and physical examination including assessment of severe bleeding every week until week 4 every second week until week 20 Complete blood count every week until week 10 For the adjustment of the Thrombopoietin receptor agonist TPO-RA dose - every second week until week 20 Immunologic panel at the beginning and at week 3 and 20
2 Follow-up
Three clinical visits are scheduled in the follow-up including a complete blood count at week 22 24 and 30 Immunologic panel will be done at week 30 end of study
High-dose dexamethasone HD-DXM will be administered orally 40 mg from day 1-4 followed by Arm 1 or 2 11 randomization
Arm 1 Standard Arm No planed further treatment standard therapy In case of non-response after 2 courses of HD-DXM week 4 cross-over to Arm 2 Start Eltrombopag Revolade 50 mg PO until day 140 details see Arm 2
In case of relapse repeat HD-DXM 40 mg day 1-4 up to a maximal of 3 courses Time between 2 courses should be minimal 14 days In case of re-relapse after the third course cross-over to Arm 2 Start Eltrombopag Revolade 50 mg PO until day 140 details see Arm 2
Arm 2 Study Arm Eltrombopag Revolade 50 mg per os from day 5-140 Tapering over 1 week from day 141-148 with 50 mg every second day
In case of non-response after 4 weeks on eltrombopag drop out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None