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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01814800 | Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD) | PHASE3 | COMPLETED | 59 | — | — | Feb 1, 2014 | Jan 1, 2015 | Oct 5, 2016 | 9 | United States |
The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.
| Arm | Type | Description |
|---|---|---|
| RI-002 Treatment | EXPERIMENTAL | Drug: RI-002 Dose: 300-800 mg/kg infusion Frequency: Once every 3 to 4 Weeks |
| Name | Type | Description |
|---|---|---|
| RI-002 | BIOLOGICAL | Immune Globulin Intravenous (IGIV) |
Inclusion Criteria: To be eligible to participate in this study, the subjects must meet the following criteria: 1. Signed a written informed consent or a specific assent form for minors. 2. Have a diagnosis of primary immunodeficiency disease. 3. Be ≥ 2 years and ≤ 75 years. 4. Have body weight ≥ ...