Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01762761 | Eltrombopag Phase III Study In Chinese Chronic ITP Patients | PHASE3 | COMPLETED | 155 | — | — | Feb 18, 2013 | Nov 22, 2018 | Dec 3, 2019 | 18 | China |
The number of participants (responders) with platelet count \>=50x10\^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing.
| Arm | Type | Description |
|---|---|---|
| Eltrombopag (ETB115) | EXPERIMENTAL | Thrombopoietin- receptor (TPO-R) agonist |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| eltrombopag | DRUG | TPO-R agonist |
| placebo | DRUG | placebo |
Inclusion Criteria: 1. Subject is ≥18 years old. 2. Diagnosed with ITP for at least 12 months prior to screening, and have a platelet count of \<30 X109/L on Day 1 (or within 48 hours prior to dosing on Day 1). 3. Patients who have no response or relapsed after splenectomy. Or patients who have not...