Stop TPO-receptor agonist in ITP Patients

Stop TPO-receptor agonist in ITP Patients - STIP study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54835

Enrollment

Registered

2016-11-30

Start date

2017-07-27

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune trombocytopenia ITP

Interventions

1 year TPO-RA use, then tapering off in 6 weeks.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Persistent or chronic ITP, 18 years old, in need of second line therapy after initial treatment with corticosteroids, informed consent

Exclusion criteria

Exclusion criteria: Previous splenectomy, Bone marrow disease, Other bleeding disorder, Liver disease (Child Pugh above 7), Pregnancy, Secondary ITP, prior TPO-RA use (longer than 3 months of therapy)

Design outcomes

Primary

Measure	Time frame
Primary outcome: Treatment success after 1 year of TPO-RA therapy. Success is durable response 4 weeks after tapering TPO-RA off at T3.	—

Secondary

Measure	Time frame
Secondary outcomes: Predictive value of 4 predictors defined in the figure above for successful tapering off. Remission rate after cessation TPO-RA at 12 months after cessation, QoL, Cost of drugs, Hospitalisation, Bleeding grade 3 or 4.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)