OASIS-HAE
15 evidence topics · 3 sources
Objective
Prophylaxis objective
Location and study date
No evidence found.
Study design
Eligibility criteria
Treatment
Study outcomes
Rationale for using HAE attack rate per four weeks as the primary endpoint
Primary clinical endpoint: attack rate over the 24-week treatment period
Statistical analysis description
Number of participants (Planned and analyzed)
Planned enrollment
| Population | Participants |
|---|---|
| Planned total | “84” |
Description of analysis sets
Results
Participant disposition
Treatment exposure
| Population | Participants |
|---|---|
| Treated | “90” |
Baseline characteristics
Efficacy results
Health-related quality of life and patient-reported outcomes
AE-QoL improvement relative to placebo at week 25: every-four-week regimen
Safety results
Study limitations
Summary
The study treated 90 participants, with 45 receiving donidalorsen every four weeks, 23 receiving it every eight weeks, and 22 receiving placebo. The full analysis set required at least one dose, rather than including every randomized participant regardless of exposure. The evidence describes a 24-week placebo-controlled comparison of repeated prophylaxis and does not directly compare donidalorsen with lonvo-z. The smaller every-eight-week and placebo groups limit precision for uncommon adverse events.