Sustained remission after 1 year of TPO-RA treatment is about 15%. Secondly, we hypothesize change occurs during 1 year treatment with TPO-RA in auto-antibodies, T regulatory cells, TPO levels and/or ITP liver/spleen scan which might predict the…
ID
Bron
Verkorte titel
Aandoening
Chronic Immune Thrombocytopenia, ITP, TPO-RA, romiplostim, discontinuation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Remission vs non-remission at 4 weeks after discontinuation of romiplostim treatment
Achtergrond van het onderzoek
Thrombopoietin receptor agonists (TPO-RAs) are a second line treatment for chronic immune thrombocytopenia (ITP). A major disadvantage of TPO-RAs is they are considered symptomatic therapy and need to be prescribed lifelong with several associated adverse events. Furthermore, TPO-RA’s are expensive and have a large impact on the medical budget. Recent literature suggests between 26-52% of patients achieve prolonged remission of ITP after stopping TPO-RA. We aim to study the remission rate after safe discontinuation of TPO-RA treatment. Furthermore, we want to study if it is possible to predict remission success with patient characteristics, immunological markers and platelet sequestration patterns.
Doel van het onderzoek
Sustained remission after 1 year of TPO-RA treatment is about 15%. Secondly, we hypothesize change occurs during 1 year treatment with TPO-RA in auto-antibodies, T regulatory cells, TPO levels and/or ITP liver/spleen scan which might predict the success rate after cessation of TPO-RA.
Onderzoeksopzet
Baseline, 1-3 month, 6 monyhs, 1 year, 2 year.
Onderzoeksproduct en/of interventie
Tapering and discontinuation of romiplostim after 1 year.
Algemeen / deelnemers
Els Borst-Eilersplein 275
Den Haag 2545 AA
The Netherlands
0622389670
s.amini@hagaziekenhuis.nl
Wetenschappers
Els Borst-Eilersplein 275
Den Haag 2545 AA
The Netherlands
0622389670
s.amini@hagaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Chronic primary ITP
• >18 years old
• Indication for second line treatment
• Informed Consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Splenectomy in history
• Secondary ITP
• Pregnancy or planning to become pregnant during the study period
• Hematologic/bone marrow/platelet disease in history or in co-existence
• Other bleeding disorder
• Liver disease (Child Pugh >7)
• Prior TPO-RA use
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6605 |
| NTR-old | NTR6787 |
| CCMO | NL58678.098.16 |
| OMON | NL-OMON54835 |