NCT02267226 is a Phase 3 clinical trial of Octafibrin in Congenital Fibrinogen Deficiency, sponsored by Octapharma.

Who is sponsoring NCT02267226?

NCT02267226 is sponsored by Octapharma.

What drugs are being tested in NCT02267226?

Interventions in NCT02267226: Octafibrin.

What condition does NCT02267226 study?

NCT02267226 studies Congenital Fibrinogen Deficiency.

Is NCT02267226 still recruiting?

NCT02267226 is currently completed. Last updated 21 December 2020.

Are results published for NCT02267226?

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

Last reviewed 2020-12-21 · How we verify

NCT02267226

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

Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy and Safety of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Subjects With Congenital Fibrinogen Deficiency

Completed Phase 3 Results posted Last updated 21 December 2020

What this trial tests

Phase 3 trial testing Octafibrin in Congenital Fibrinogen Deficiency in 25 participants. Completed in 14 February 2018.

Timeline

1 September 2014

Primary endpoint
14 February 2018

14 February 2018

Quick facts

Lead sponsor	Octapharma
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 September 2014
Primary completion	14 February 2018
Estimated completion	14 February 2018
Sites	12 locations across United States, Bulgaria, India, Iran, Lebanon, Russia, Saudi Arabia, Turkey (Türkiye)

Drugs / interventions tested

Octafibrin — full drug profile →

Conditions studied

Congenital Fibrinogen Deficiency — all drugs for Congenital Fibrinogen Deficiency →

Sponsor

Octapharma — full company profile →

Who can join

12 and older, any sex, with Congenital Fibrinogen Deficiency. 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.

Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient.
Time frame: 24 hours after last infusion for each bleeding episode
The first bleeding episode covers the time period from the first Octafibrin infusion until 24 hours (i.e., 1 day) after the last infusion. The investigator's overall clinical assessment of haemostatic efficacy for bleeding was based on a 4 point haemostatic efficacy scale. The final efficacy assessment of each patient was adjudicated by the Independent Data Monitoring \& Endpoint Adjudication Com

Sponsor's own description

The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Fibrinogen concentrate for treatment of bleeding and surgical prophylaxis in congenital fibrinogen deficiency patients.
Lissitchkov T, Madan B, Djambas Khayat C, Zozulya N, et al · · 2020 · cited 21× · PMID 31885190 · DOI 10.1111/jth.14727
Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of a Phase III trial.
Lissitchkov T, Madan B, Djambas Khayat C, Zozulya N, et al · · 2018 · cited 13× · PMID 29194665 · DOI 10.1111/trf.14421
Efficacy and safety of fibrinogen concentrate for perioperative prophylaxis of bleeding in adult, adolescent, and pediatric patients with congenital fibrinogen deficiency: FORMA-02 and FORMA-04 clinical trials.
Khayat CD, Lohade S, Zekavat OR, Kruzhkova I, et al · · 2022 · cited 2× · PMID 35932202 · DOI 10.1111/trf.17029

Verify or expand the search:

Other trials of Octafibrin

Trials testing the same drug.

NCT03037424 — FIBrinogen REplenishment in Surgery · Phase 3 · completed

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 NCT02267226 (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: 21 December 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/NCT02267226.

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