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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00621894 | Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation | PHASE2 | COMPLETED | 23 | — | — | Mar 15, 2008 | May 15, 2009 | Dec 16, 2024 | 15 | United States |
Response was defined as platelet count \>= 50 x1000/uL for participants without Baseline steroid uses; or platelet counts \>= 50 x1000/uL and doubling the Baseline platelet counts for participants with baseline steroid uses. Confidence interval of response rate was computed using exact method of binomial proportion.
| Arm | Type | Description |
|---|---|---|
| LGD4665 | EXPERIMENTAL | LGD-4665: Experimental Thrombopoietin mimetic |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| LGD-4665 | DRUG | LGD-4665 Thrombopoietin mimetic |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Adults 18 years or older * Diagnosis of ITP for at least 3 months consistent with ASH guidelines * Treated with one or more prior therapies for ITP and platelet counts \< 30,000/µL or \< 50,000/µL if on a stable oral corticosteroid for ≥ 4 weeks, supported by 2 platelet counts...