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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01148953 | Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) Amyloidosis | PHASE1 | COMPLETED | 32 | — | — | Jun 1, 2010 | Feb 1, 2012 | May 24, 2012 | 4 | France, Portugal +2 |
| Arm | Type | Description |
|---|---|---|
| ALN-TTR01 | ACTIVE_COMPARATOR | - |
| Sterile Normal Saline (0.9% NaCl) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALN-TTR01 | DRUG | Dose levels between 0.01 and 1.0 mg/kg by intravenous (IV) infusion |
| Sterile Normal Saline (0.9% NaCl) | DRUG | Calculated volume to match active comparator |
Inclusion Criteria: * Diagnosis of TTR amyloidosis * Adequate blood counts, liver and renal function * Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control * Males agree to use appropriate contraception * Wi...