At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
Givosirandrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety and Clinical Activity of Subcutaneously Administered ALN-AS1 in Patients With Acute Intermittent Porphyria Who Have Completed a Previous Clinical Study With ALN-AS1
In Brief
A Phase 2 clinical trial evaluating Givosiran for Acute Intermittent Porphyria. Completed, enrolled 16 participants across 5 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients who completed study ALN-AS1-001 (NCT02452372).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Intermittent Porphyria
CountriesSweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedOct 2016
Primary CompletionNov 2021
TodayJul 2026
First PostedOct 31, 2016
Enrollment StartOct 1, 2016
Primary CompletionNov 5, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 9.7 years ago
Interventions
Givosirandrug
Givosiran by subcutaneous (SC) injection.