Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Immune Globulin · 1 trial · 1 indication
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...
Immune Globulin is an investigational monoclonal antibody being developed for the treatment of Primary Immunodeficiency. It is administered intravenously as a 10% solution. The drug is currently in Phase 3 clinical development, though the Phase 3 trial has been completed.
Immune Globulin is a monoclonal antibody that provides passive immunity by supplying antibodies to patients with Primary Immunodeficiency. It works by replacing the missing or deficient antibodies in these patients, helping to protect them against infections.
Immune Globulin is being developed by Atlantic International Corp., a company traded under the ticker ATLN. The drug is being studied for the treatment of Primary Immunodeficiency, a condition in the immunology therapeutic area.
Immune Globulin is in Phase 3 clinical development. The Phase 3 trial has been completed, and the drug remains investigational. It has not been approved by the FDA, as it is still in clinical development.
Immune Globulin has one completed Phase 3 clinical trial, NCT02269163, titled 'Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%'. This trial enrolled 82 participants with Primary Immunodeficiency in the United States and included patients as young as 2 years old.