Trials / Completed
CompletedNCT01938378
Octaplas Pediatric Plasma Exchange Trial
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 2 Years – 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Octaplas™ | octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2019-01-27
- Completion
- 2019-01-27
- First posted
- 2013-09-10
- Last updated
- 2020-03-24
- Results posted
- 2020-03-24
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01938378. Inclusion in this directory is not an endorsement.