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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03275454 | A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) | PHASE1 | COMPLETED | 12 | — | — | Aug 14, 2017 | Feb 16, 2021 | May 18, 2023 | 5 | United States, Germany +1 |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of participants with premature study terminations will be assessed.
Clinical laboratory abnormalities including one or more specific target-organs for toxicity of BIVV009, abnormalities in D-dimer, thrombin-anti-thrombin assay, and Systemic Lupus Erythematosus (SLE) panel.
| Arm | Type | Description |
|---|---|---|
| BIVV009 | EXPERIMENTAL | Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009 intravenous (IV) infusion and participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009 every 2 weeks for approximately 21 weeks in Part A (based on time to complete 11 doses of study drug). There will be a 9-week safety follow-up/washout period after administration of the last dose of study drug in Part A. Participants who have been shown to benefit from BIVV009 treatment during Part A, will receive BIVV009 (based on weight) biweekly for up to 52 weeks of BIVV009 after Last Patient In (LPI) in part B. |
| Name | Type | Description |
|---|---|---|
| BIVV009 6.5 grams | DRUG | Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009. |
| BIVV009 7.5 grams | DRUG | Participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009. |
Inclusion Criteria Part A: * Chronic immune thrombocytopenia (ITP) (ITP lasting for greater than or equal to (\[\>=\] 12 months) as defined in the protocol * Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) * No history of a coagulation disorder * Hemoglobin level ...