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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00632463 | RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness | PHASE2 | COMPLETED | 21 | — | — | Feb 1, 2008 | May 1, 2010 | Apr 24, 2013 | 19 | United States, Canada |
The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Dose regimen 1 |
| 2 | EXPERIMENTAL | Dose regimen 2 |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| RI-001 | BIOLOGICAL | Dose 1 |
Inclusion Criteria: 1. An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors. 2. Documented Bone Marrow Transplant (BMT)/Hema...