A controlled, randomised, study investigating the pharmacokineticproperties (to see how active the study drug is in your blood and how long it takes for the study drug to get out of your blood) , surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency

A prospective, controlled, randomised, cross-over study investigating the pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency - NA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002403-15-GB

Enrollment

Registered

2011-11-25

Start date

2012-08-07

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital fibrinogen deficiency MedDRA version: 16.0 Level: LLT Classification code 10052651 Term: Afibrinogenaemia System Organ Class: 100000004850

Interventions

Product Name: octafibrin Pharmaceutical Form: Powder for solution for injection CAS Number: 9001-32-5 Other descriptive name: HUMAN FIBRINOGEN Concentration unit: mg/kg milligram(s)/kilogram Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Subject age =12 years • Documented congenital fibrinogen deficiency (afibrinogenaemia) Plasma fibrinogen activity and antigen at screening bellow detection limit (i.e. =65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: • Life expectancy 200 particles/µl ~ >400000 copies/ml • Polytrauma 1 year prior to enrolment • Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery if available <0.5 (mg/dl)/(mg/kg), (there is currently no standard test for inhibitors) • Blood or plasma donation in the 3 months prior to enrolment

Design outcomes

Primary

Measure	Time frame
Main Objective: • To determine the single dose pharmacokinetics of Octafibrin and Haemocomplettan® P/RiaSTAPTM in subjects with congenital fibrinogen deficiency • To determine maximum clot strength (maximum clot firmness [MCF]) as a surrogate marker for haemostatic efficacy before and after administration of Octafibrin and Haemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency ;Secondary Objective: To assess the safety of Octafibrin in subjects with congenital fibrinogen deficiency;Primary end point(s): A comparison of the AUC between Octafibrin and Haemocomplettan® P/RiaSTAPTM Surrogate endpoint for haemostatic efficacy Comparison of MCF between Octafibrin and Haemocomplettan® P/RiaSTAPTM at 1 hour post-infusion ;Timepoint(s) of evaluation of this end point: at baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 312 hours post-infusion.	—

Measure

Time frame

Main Objective: • To determine the single dose pharmacokinetics of Octafibrin and Haemocomplettan® P/RiaSTAPTM in subjects with congenital fibrinogen deficiency • To determine maximum clot strength (maximum clot firmness [MCF]) as a surrogate marker for haemostatic efficacy before and after administration of Octafibrin and Haemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency ;Secondary Objective: To assess the safety of Octafibrin in subjects with congenital fibrinogen deficiency;Primary end point(s): A comparison of the AUC between Octafibrin and Haemocomplettan® P/RiaSTAPTM Surrogate endpoint for haemostatic efficacy Comparison of MCF between Octafibrin and Haemocomplettan® P/RiaSTAPTM at 1 hour post-infusion ;Timepoint(s) of evaluation of this end point: at baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 312 hours post-infusion.

—

Secondary

Measure	Time frame
Secondary end point(s): • To compare the in vivo recovery between Octafibrin and Haemocomplettan® P/ RiaSTAPTM • To compare the pharmacokinetics between Octafibrin and Haemocomplettan® P/ RiaSTAPTM • To document the safety of Octafibrin ;Timepoint(s) of evaluation of this end point: at baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216 and 312 hours post-infusion.	—

Countries

Bulgaria, Germany, Iran, Islamic Republic of, Italy, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactProject Manager

QED CLinical Services Ltd

hwide@qed-clinical.com4401908251487

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026