At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 41 enrolled
Drug / intervention
Octaplas™biological
Likely dose
Octaplas™ 60 mlfrom 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.
An Open-label, Multicenter, Post-Marketing Requirement Study to Investigate the Safety and Tolerability of Octaplas™ in the Management of Pediatric Patients Who Require Therapeutic Plasma Exchange
In Brief
A Phase 4 clinical trial evaluating Octaplas™ for Adverse Effects in the Therapeutic Use of Plasma Substitutes. Completed, enrolled 41 participants across 8 sites.
Detailed Summary
To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric patients who require therapeutic plasma exchange.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartApr 2015
Primary CompletionJan 2019
TodayJul 2026
First PostedSep 10, 2013
Enrollment StartApr 1, 2015
Primary CompletionJan 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.8 years ago
Interventions
Octaplas™biological
octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.