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NCT01938378 · ClinicalTrials.gov registry record · Phase 4
Octaplas Pediatric Plasma Exchange Trial
A Phase 4 study of Adverse Effects in the Therapeutic Use of Plasma Substitutes, sponsored by Octapharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
- 8
- Study locations
NCT01938378: Completed Phase 4 study of Adverse Effects in the Therapeutic Use of Plasma Substitutes, sponsored by Octapharma.
NCT01938378 is a Phase 4 study of Adverse Effects in the Therapeutic Use of Plasma Substitutes that has completed, run by Octapharma. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01938378, a Phase 4 study of Adverse Effects in the Therapeutic Use of Plasma Substitutes, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.
Conditions Studied
Interventions
- BIOLOGICAL Octaplas™
Study Locations (8)
Missouri
- Octapharma Research Site - Kansas City
- Octapharma Research Site - St Louis
Alabama
- Octapharma Research Site - Birmingham
Georgia
- Octapharma Research Site - Atlanta
Louisiana
- Octapharma Research Site - New Orleans
Minnesota
- Octapharma Research Site - Minneapolis
North Carolina
- Octapharma Research Site - Durham
Ohio
- Octapharma Research Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-01-27 |
| Phase | Phase 4 |
What the finished NCT01938378 record still lists
NCT01938378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Adverse Effects in the Therapeutic Use of Plasma Substitutes appearing as the primary indexed condition, and to 1 intervention - of which Octaplas™ is the first listed.
NCT01938378 lists 8 locations in 7 states (Missouri, Alabama, Georgia).
Frequently Asked Questions
What is clinical trial NCT01938378 about?
NCT01938378 is a clinical study titled "Octaplas Pediatric Plasma Exchange Trial". 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 therapeuti...
What is the current status of trial NCT01938378?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2015-04. Estimated completion is 2019-01-27.
What conditions does trial NCT01938378 study?
This clinical trial studies the following conditions: Adverse Effects in the Therapeutic Use of Plasma Substitutes.
What interventions are being tested in trial NCT01938378?
The interventions under investigation include: Octaplas™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT01938378?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01938378 being conducted?
This trial has 8 study locations across Alabama, Georgia, Louisiana, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01938378's enrollment target sits among peer trials
41 1390th of 2000 higher than 605 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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