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A multicentre, randomized, open-label study of romiplostim plus dexamethasone vs dexamethasone in patients with newly diagnosed primary immune thrombocytopenia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514147-28-00
Acronym
RODEX
Enrollment
86
Registered
2024-07-15
Start date
2022-12-02
Completion date
Unknown
Last updated
2025-12-12

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

Conditions

Primary immune thrombocytopenia

Brief summary

To evaluate the difference between study arms in the proportion of patients achieving 6mSROT-50 at 6 months (180 days) from treatment cessation. Definition of 6mSROT-50: platelets higher or equal than 50x109/L in the absence of any ITP treatment including any rescue treatment for at least 6 consecutive months (≥180 days) from treatment cessation and without WHO grade 2 or more bleeding.

Detailed description

-To evaluate the difference between study arms in the proportion of patients achieving 6mSROT-30 at 6 months (180 days) from treatment cessation. -To evaluate the difference between study arms in the proportion of patients achieving 12mSROT-50 at 12 months (365 days) from treatment cessation. -To evaluate the difference between study arms in the proportion of patients achieving 12mSROT-30 at 12 months (365 days) from treatment cessation

Interventions

DRUGDEXAMETHASONE
DRUGNplate 500 micrograms powder and solvent for solution for injection
DRUGNplate 250 micrograms powder for solution for injection

Sponsors

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To evaluate the difference between study arms in the proportion of patients achieving 6mSROT-50 at 6 months (180 days) from treatment cessation. Definition of 6mSROT-50: platelets higher or equal than 50x109/L in the absence of any ITP treatment including any rescue treatment for at least 6 consecutive months (≥180 days) from treatment cessation and without WHO grade 2 or more bleeding.—

Secondary

MeasureTime frame
-To evaluate the difference between study arms in the proportion of patients achieving 6mSROT-30 at 6 months (180 days) from treatment cessation. -To evaluate the difference between study arms in the proportion of patients achieving 12mSROT-50 at 12 months (365 days) from treatment cessation. -To evaluate the difference between study arms in the proportion of patients achieving 12mSROT-30 at 12 months (365 days) from treatment cessation—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026