Who is sponsoring NCT01938378?

NCT01938378 is sponsored by Octapharma.

What drugs are being tested in NCT01938378?

Interventions in NCT01938378: Octaplas™.

What condition does NCT01938378 study?

NCT01938378 studies Adverse Effects in the Therapeutic Use of Plasma Substitutes.

Is NCT01938378 still recruiting?

NCT01938378 is currently completed. Last updated 23 March 2020.

Are results published for NCT01938378?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-03-23 · How we verify

NCT01938378: Octaplas

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 23 March 2020

What this trial tests

Phase 4 trial testing Octaplas™ in Adverse Effects in the Therapeutic Use of Plasma Substitutes in 41 participants. Completed in 27 January 2019.

Timeline

1 April 2015

Primary endpoint
27 January 2019

27 January 2019

Quick facts

Lead sponsor	Octapharma
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	1 April 2015
Primary completion	27 January 2019
Estimated completion	27 January 2019
Sites	8 locations across United States

Drugs / interventions tested

Octaplas™

Conditions studied

Adverse Effects in the Therapeutic Use of Plasma Substitutes — all drugs for Adverse Effects in the Therapeutic Use of Plasma Substitutes →

Sponsor

Octapharma — full company profile →

Who can join

Adults 2 to 20, any sex, with Adverse Effects in the Therapeutic Use of Plasma Substitutes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.
Time frame: up to 8 days including the 24 hour follow-up from treatment
Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.
Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.
Time frame: up to 8 days including the 24 hour follow-up from treatment
Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and tolerability of solvent/detergent-treated plasma for pediatric patients requiring therapeutic plasma exchange: An open-label, multicenter, postmarketing study.
Josephson CD, Goldstein S, Askenazi D, Cohn CS, et al · · 2022 · cited 7× · PMID 34931321 · DOI 10.1111/trf.16775

Verify or expand the search:

Other Octapharma trials

Trials by the same sponsor.

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NCT04918173 — Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery · Phase 3 · recruiting
NCT04953884 — Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age · Phase 3 · completed
NCT04508530 — Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01938378 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Octapharma
Last refreshed: 23 March 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01938378.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing