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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.

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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.

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

FieldValue
Enrollment Target 41 participants
Start Date 2015-04
Est. Completion 2019-01-27
Phase Phase 4
Octapharma

43 total trials

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.

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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Source: ClinicalTrials.gov NCT01938378, the US trial registry maintained by the National Library of Medicine. NCT01938378 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.