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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01757418 | Intravenous Gammaglobulin for Sickle Cell Pain Crises | PHASE1 | COMPLETED | 300 | — | — | Nov 1, 2008 | Dec 18, 2024 | Mar 31, 2026 | 1 | United States |
Length (duration) of vaso-occlusive crisis as measured from the time of presentation to the emergency room to end of VOC defined as 12 hours from the last dose of parenteral opioid analgesia for the treatment of VOC prior to hospital discharge. Group results will be summarized in number of days using univariate statistics.
| Arm | Type | Description |
|---|---|---|
| Intravenous Immune Globulin (IVIG) | EXPERIMENTAL | IVIG used in the trial is the GAMUNEX brand, at doses up through 800 mg/kg in Phase 1 and at 400mg/kg in Phase 2. |
| Normal saline | PLACEBO_COMPARATOR | An equivalent volume (weight-based) of normal saline |
| Name | Type | Description |
|---|---|---|
| Immune Globulin Intravenous (IVIG) | DRUG | A single dose of intravenous immune globulin administered within 24 hours of hospital presentation. The maximum dose in Phase I was 800 mg/kg. The dose for Phase II is 400mg/kg. |
| Normal saline | OTHER | A single dose of normal saline administered within 24 hours of hospital admission for uncomplicated pain crisis. |
Each subject must fulfill each of the following Inclusion/Exclusion criteria at screening and continue to fulfill these criteria prior to dosing: Inclusion Criteria: * Documented Sickle Cell Disease (SS or S-β thalassemia genotype) * Age 12-65 years for Phase 1 (Completed), 6-13.99 years for Phase...