NCT02050841 is a Phase 4 clinical trial of octaplas in Liver Surgery, sponsored by Octapharma.

Who is sponsoring NCT02050841?

NCT02050841 is sponsored by Octapharma.

What drugs are being tested in NCT02050841?

Interventions in NCT02050841: octaplas.

What condition does NCT02050841 study?

NCT02050841 studies Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery.

Is NCT02050841 still recruiting?

NCT02050841 is currently completed. Last updated 9 June 2020.

Are results published for NCT02050841?

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

Last reviewed 2020-06-09 · How we verify

NCT02050841

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 (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors.

Completed Phase 4 Results posted Last updated 9 June 2020

What this trial tests

Phase 4 trial testing octaplas in Liver Surgery in 50 participants. Completed in 4 December 2017.

Timeline

1 December 2014

Primary endpoint
4 December 2017

4 December 2017

Quick facts

Lead sponsor	Octapharma
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 December 2014
Primary completion	4 December 2017
Estimated completion	4 December 2017
Sites	4 locations across United States

Drugs / interventions tested

octaplas — full drug profile →

Conditions studied

Liver Surgery — all drugs for Liver Surgery →
Liver Dysfunction — all drugs for Liver Dysfunction →
Coagulopathy — all drugs for Coagulopathy →
Cardiac Surgery — all drugs for Cardiac Surgery →

Sponsor

Octapharma — full company profile →

Who can join

Under 16, any sex, with Liver Surgery or Liver Dysfunction. 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.

Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Time frame: up to 6 days
Monitoring of Clinically Significant Changes in White Blood Cells
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Red Blood Cells
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Hemoglobin
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Hematocrit
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1

Sponsor's own description

The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors. Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver surgery.

Publications & conference data

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

Solvent/Detergent-Treated Plasma in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors: An Open-Label, Multicenter, Post-marketing Study.
Spinella PC, Borasino S, Alten J. · · 2020 · cited 8× · PMID 33042916 · DOI 10.3389/fped.2020.00572

Verify or expand the search:

Other recruiting trials for Liver Surgery

Currently open trials in the same condition.

NCT07192575 — Prevention of Pulmonary Complications After Laparoscopic Liver Surgery · NA · recruiting
NCT03270917 — ORANGE SEGMENTS: Open Versus Laparoscopic Parenchymal Preserving Postero-Superior Liver Segment Resection · NA · active not recruiting

Other Octapharma trials

Trials by the same sponsor.

NCT06429787 — Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Antico · recruiting
NCT05523297 — Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery · Phase 3 · completed
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 NCT02050841 (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: 9 June 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/NCT02050841.

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