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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02269163 | Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% | PHASE3 | COMPLETED | 82 | — | — | Jan 26, 2016 | Jan 11, 2019 | Nov 5, 2021 | 13 | United States |
SBIs were calculated for each subject as 52n/w, where n is the number of reported SBIs and w is the number of weeks on study. For the combined cohorts only, a 99% one-sided (upper) confidence limit for the incidence rate of SBIs (scaled to represent 12 months exposure if necessary) was derived, and the objective of demonstrating that the true infection rate was below 1 per subject per year was considered established if this upper limit was less than 1. To calculate the confidence limit, a negative binomial regression model will be used. This model includes an overdispersion parameter to account for possible intra-subject correlation as well as the actual time period each subject is on the study as an offset variable.
| Arm | Type | Description |
|---|---|---|
| Gammargard, Gammaplex, Gamunex, or Octogam Treatment Period | ACTIVE_COMPARATOR | Subjects who enroll in the study while on Gammargard, Gammaplex, Gamunex, or Octogam IGIV Product and need to wait for the scheduled start of Prometic IGIV (10%) treatment will continue on their usual dose and treatment cycle with Gammargard, Gammaplex, Gamunex, or Octogam IVIG Product during this period. |
| Prometic IGIV 10% Treatment Period | EXPERIMENTAL | Subjects will receive Prometic Immune Globulin Intravenous 10% |
| Name | Type | Description |
|---|---|---|
| Immune Globulin Intravenous | BIOLOGICAL | Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product |
| Prometic's Immune Globulin Intravenous 10% | BIOLOGICAL | Liquid formulation of Prometic Immune Globulin Intravenous 10% (human) in 50 mL vials containing 100 mg/mL of immunoglobulin G (IgG) |
Inclusion Criteria: 1. Subject is male or female between the ages of 2 and 80 years at Screening. 2. Female subjects of childbearing potential must agree to employ adequate birth control measures, as determined by their IRB/IEC, for the duration of the study. 3. The subject must have one of the fol...