Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. FDA label
Romiplostim · 1 trial · 1 indication
number of patients in whom Platelet Counts measured on days 8 and 15 after eltrombopag treatment increase to \> 50,000/uL counts on other days are just used to be sure the ones on days 8 and 15 are reasonably accurate and representative
number of participants in whom platelet counts measured on day 8 and day 15 after treatment(s) with romiplostim 10 micrograms/kg on days 1 and 8
| Arm | Type | Description |
|---|---|---|
| eltrombopag | EXPERIMENTAL | 10 ITP patients were treated with daily oral eltrombopag 75mg for 2 weeks and complete testing was done at weekly intervals 3 times they then were allowed to receive long-term eltrombopag |
| romiplostim | EXPERIMENTAL | 3 of the patients who received eltrombopag were also treated with romiplostim 10 micrograms/kg weekly for 2 weeks with the same complete testing done at weekly intervals three times after a washout period \> 1 month they then resumed long-term eltrombopag |
| healthy controls | SHAM_COMPARATOR | no intervention single blood draw with complete studies |
| Name | Type | Description |
|---|---|---|
| Eltrombopag | DRUG | The 10 subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times, weekly, for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months. |
| Romiplostim | DRUG | three of the patients treated with eltrombopag will be treated with weekly romiplostim at a dose of 10 micrograms/kg weekly for 2 weeks with testing at weekly intervals for 3 times |
| healthy controls | OTHER | single blood draw for all measures included in the intervention arms |
Inclusion Criteria: * Subject has signed and dated a written informed consent * Male or female adults (≥18 years) diagnosed with either primary ITP according to the American Society for Hematology or British Committee for Standards in Haematology (ASH/BCSH) guidelines \[Blood, 1996; British Journal...