Following Longitudinally the Outcome of nonsevere hemophilia A patients that are treated With FVIII concentrates for bleeding or surgery.

Following Longitudinally the Outcome of nonsevere hemophilia A patients that are treated With FVIII concentrates for bleeding or surgery. - FLOW

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46704

Enrollment

Registered

2017-12-18

Start date

2018-06-04

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

factor VIII deficiency nonsevere hemophilia A

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Nonsevere Hemophilia A patient or Hemophilia A carrier Need for FVIII treatment for bleeding or surgery

Exclusion criteria

Exclusion criteria: Use of immunosuppressive medication Presence of immunological disease Presence of FVIII inhibitors

Design outcomes

Primary

Measure	Time frame
The primary outcome is the identification of: 1. Markers of an immune system prone for the development of inhibitors. ; 2. Markers of systemic inflammation that may indicate risk of an anti-FVIII immune response, before inhibitors occur. Determinants that will be assessed are subdivided in following categories: (1) patient specific determinants (F8 gene mutation and other known genomic predictors), (2) treatment specific determinants (reason for treatment, intensity of treatment, occurrence of an infection) and (3) immunological determinants (FVIII specific T and B cell responses, RNA expression profiles and biomarkers).	—

Measure

Time frame

The primary outcome is the identification of: 1. Markers of an immune system prone for the development of inhibitors. ; 2. Markers of systemic inflammation that may indicate risk of an anti-FVIII immune response, before inhibitors occur. Determinants that will be assessed are subdivided in following categories: (1) patient specific determinants (F8 gene mutation and other known genomic predictors), (2) treatment specific determinants (reason for treatment, intensity of treatment, occurrence of an infection) and (3) immunological determinants (FVIII specific T and B cell responses, RNA expression profiles and biomarkers).

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results