At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
Patisirandrug
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 Phase 2, Open-Label, Multi-Dose, Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusions of ALN-TTR02 in Patients With TTR Amyloidosis
In Brief
A Phase 2 clinical trial evaluating Patisiran for TTR-mediated Amyloidosis. Completed, enrolled 29 participants across 10 sites in 7 countries.
Detailed Summary
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTTR-mediated Amyloidosis
CountriesBrazil, France, Germany, Portugal, Spain, Sweden, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedJun 2012
Primary CompletionOct 2013
Study CompletionJan 2014
TodayJul 2026
First PostedJun 13, 2012
Enrollment StartMay 1, 2012
Primary CompletionOct 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.1 years ago
Interventions
Patisirandrug
Participants received a single dose of patisiran as an intravenous (IV) infusion on Day 0 and Day 28 (Q4W). Optional cohorts received an alternative dosing regimen (once every 3 weeks \[Q3W\]: Day 0 and Day 21) and an alternative premedication regimen.