Standard vs. product-specific calibration for determining the activity of efanesoctocog alfa in post-infusion samples

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039894

Enrollment

Registered

2026-06-25

Start date

2026-07-13

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

D66

Interventions

Group 1: The study is based, on the one hand, on a retrospective analysis of existing patient data. Samples from patients were examined in whom the activity of Efanesoctocog alfa was determined betwee

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Data analysis of patient data obtained between March 2025 and February 2026

Exclusion criteria

Exclusion criteria: Failure to perform analysis using standard and product-specific calibration

Design outcomes

Primary

Measure	Time frame
The objective and rationale of this retrospective analysis of relevant measurement values from patient samples is to determine whether product-specific calibration also yields sufficiently accurate test results for post-infusion samples, compared to the gold standard—an Actin FSL-based determination of the activity of efanesoctocog alfa under standard calibration. The following endpoints are defined: - Deviation of measurement results from post-infusion samples under product-specific calibration compared to standard calibration. - Deviation of measurement results from post-infusion samples under product-specific calibration from those of the gold standard (Actin FSL-based OSCA under standard calibration). - Comparison of the deviation of measurement results from post-infusion samples from those of spiked sample material.	—

Measure

Time frame

The objective and rationale of this retrospective analysis of relevant measurement values from patient samples is to determine whether product-specific calibration also yields sufficiently accurate test results for post-infusion samples, compared to the gold standard—an Actin FSL-based determination of the activity of efanesoctocog alfa under standard calibration. The following endpoints are defined: - Deviation of measurement results from post-infusion samples under product-specific calibration compared to standard calibration. - Deviation of measurement results from post-infusion samples under product-specific calibration from those of the gold standard (Actin FSL-based OSCA under standard calibration). - Comparison of the deviation of measurement results from post-infusion samples from those of spiked sample material.

—

Countries

Germany

Contacts

Public ContactJens Müller

Uniklinikum Bonn, Institut für Exp. Hämatologie und Transfusionsmedizin

jens.mueller@ukbonn.de+4922828716735

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026