NCT01053169 is a clinical trial of Beriplex® P/N in Coagulation Protein Disorders, sponsored by CSL Behring.

Who is sponsoring NCT01053169?

NCT01053169 is sponsored by CSL Behring.

What drugs are being tested in NCT01053169?

Interventions in NCT01053169: Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma.

What condition does NCT01053169 study?

NCT01053169 studies Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care.

Is NCT01053169 still recruiting?

NCT01053169 is currently completed. Last updated 2 October 2017.

Last reviewed 2017-10-02 · How we verify

NCT01053169

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

Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)

Completed Last updated 2 October 2017

What this trial tests

trial testing Beriplex® P/N in Coagulation Protein Disorders in 445 participants. Completed in 1 January 2012.

Timeline

1 May 2010

Primary endpoint
1 January 2012

1 January 2012

Quick facts

Lead sponsor	CSL Behring
Status	Completed
Study type	OBSERVATIONAL
Enrollment	445
Start date	1 May 2010
Primary completion	1 January 2012
Estimated completion	1 January 2012
Sites	6 locations across United Kingdom

Drugs / interventions tested

Beriplex® P/N — full drug profile →
Fresh Frozen Plasma (FFP) and Beriplex® P/N — full drug profile →
Fresh Frozen Plasma — full drug profile →

Conditions studied

Coagulation Protein Disorders — all drugs for Coagulation Protein Disorders →
Blood Loss, Surgical — all drugs for Blood Loss, Surgical →
Perioperative Care — all drugs for Perioperative Care →

Sponsor

CSL Behring — full company profile →

Who can join

16 and older, any sex, with Coagulation Protein Disorders or Blood Loss, Surgical. 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.

Adequacy of stopping or preventing bleeding
Time frame: Up to 24 hours after treatment

Sponsor's own description

Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.

Publications & conference data

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

Retrospective Review of a Prothrombin Complex Concentrate (Beriplex P/N) for the Management of Perioperative Bleeding Unrelated to Oral Anticoagulation.
Chowdary P, Tang A, Watson D, Besser M, et al · · 2018 · cited 12× · PMID 29415562 · DOI 10.1177/1076029617753537

Verify or expand the search:

Other CSL Behring trials

Trials by the same sponsor.

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NCT07332091 — Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary He · Phase 2 · recruiting
NCT07094087 — Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovasc · Phase 3 · recruiting
NCT07048262 — Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NC · Phase 2 · recruiting

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 NCT01053169 (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 CSL Behring
Last refreshed: 2 October 2017

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/NCT01053169.

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