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STIP study


- candidate number28023
- NTR NumberNTR6787
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-okt-2017
- Secondary IDsNL58678.098.16 CCMO/ABR-nummer
- Public TitleSTIP study
- Scientific TitleStop TPO-receptor agonist in ITP Patients
- ACRONYMSTIP
- hypothesisSustained 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.
- Healt Condition(s) or Problem(s) studiedThrombopoietin Receptor Agonist (TPO-RA), Immune thrombocytopenia (ITP), Romiplostim
- Inclusion criteria• Chronic primary ITP
• >18 years old
• Indication for second line treatment
• Informed Consent
- Exclusion criteria• 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 27-jul-2017
- planned closingdate2-jan-2020
- Target number of participants50
- InterventionsTapering and discontinuation of romiplostim after 1 year.
- Primary outcomeRemission vs non-remission at 4 weeks after discontinuation of romiplostim treatment
- Secondary outcomePossible predictive values for successful cessation. Remission after 12 months, QoL, costs, hospitalisation.
- TimepointsBaseline, 1-3 month, 6 monyhs, 1 year, 2 year.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Amini
- CONTACT for SCIENTIFIC QUERIES S. Amini
- Sponsor/Initiator Haga Teaching Hospital, The Hague
- Funding
(Source(s) of Monetary or Material Support)
Amgen
- Publications
- Brief summaryThrombopoietin 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.
- Main changes (audit trail)
- RECORD17-okt-2017 - 16-nov-2017


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