Primary Immune Thrombocytopenia
Conditions
Keywords
Adult ITP
Brief summary
This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).
Interventions
DRUGRomiplostim
Administered subcutaneously.
DRUGPredniso(lo)ne
Administered orally.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years or adult legal age within country if older than 18 years. * Diagnosis of primary ITP according to the 2019 International Consensus (ICR) that is previously untreated and requires treatment. * Note: The investigator should ensure that the diagnosis of primary ITP is established by excluding other causes of isolated thrombocytopenia, as outlined in the 2019 ICR, which states that the diagnosis of primary ITP is principally based on the exclusion of other causes of isolated thrombocytopenia. * Note: If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion. * Note: Emergency ITP treatment with any thrombopoietin receptor agonists (TPO-RAs), or splenectomy is not allowed. * Platelet count \< 30 × 10\^9/L or Platelet count \< 50× 10\^9/L with clinically significant bleeding before any medical intervention.
Exclusion criteria
* Life-threatening bleeding at randomization. * Known sensitivity or intolerance to any of the products to be administered during study (eg, uncontrolled diabetes) or to any Escherichia coli-derived product (eg, filgrastim, pegfilgrastim, certain insulins). * Uncontrolled hypertension before randomization. * Abnormal hepatic or renal function at screening. * History of total splenectomy. * Use of concurrent anticoagulation therapy and/or antiplatelet therapy. * Need for nonsteroidal anti-inflammatory drugs (NSAIDs) use and use of NSAIDs within 7 days before randomization. * Venous or arterial thrombotic event within 3 or 6 months, respectively, before randomization. * Other protocol-defined Inclusion/Exclusion may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With a Durable Platelet Response (DPR) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to Next Treatment (TTNT) | 12 months |
| Cumulative Exposure to Corticosteroids | 12 months |
| Change From Baseline in ITP Patient Assessment Questionnaire (ITP-PAQ) | 12 months |
| Change in Summary Scores and Visual Analogue Scale (VAS) Scores per EuroQol 5-Dimension 5-Level (EQ 5D-5L) | 12 months |
| Incidence of Hospitalization and Rescue Medication in Part 1 | 6 months |
| Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Interest (EOI), and Fatal TEAEs | 12 months |
| Percentage of Participants With Clinically Significant Bleeding Events in the Immune Thrombocytopenia-specific Bleeding Assessment Tool (ITP-BAT) | 6 months |
| Serum Trough Concentration (Ctrough) of Romiplostim | 6 months |
| Number of Participants With Anti-Romiplostim Antibodies and Anti-Thrombopoietin (TPO) Antibodies | 6 months |
Countries
United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed