Genetic Influence on the distribution of Factor VIII in the patient`s blood with bleeding disorder

Genetic Influence on the Pharmacokinetic Behavor of Factor VIII - FVIII PK Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001669-34-AT

Enrollment

100

Registered

2012-06-06

Start date

2012-07-12

Completion date

Unknown

Last updated

2015-07-10

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

Conditions

Haemophilia A under prophylactic Factor VIII Substitution

Interventions

Trade Name: Advate Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: OCTOCOG ALFA CAS Number: 139076-62-3 Concentration unit: IU international unit

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: This analysis will be performed on a study cohort of approximately 100 severe hemophilia A boys.The boys will be aged between 6 and 18 years and will have severe FVIII deficiency (baseline levels =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The analysis of factor VIII clearance must be performed at a time when there is no bleeding (bleeding will use up the factor VIII and therefore shorten its circulation time). In addition, there should be no factor VIII antibodies (factor VIII inhibitors) present at the time of testing.

Design outcomes

Primary

Measure	Time frame
Main Objective: The theme of this study is to characterize the genetic factors that influence the clearence of F VIII in patients with severe hemophilia A.;Secondary Objective: ;Primary end point(s): The major issue that we may face is an influence of age on FVIII PK. This effect is well documented, but is largely present in very young children (<5 years) and is minimized by employing an optimal blood sampling schedule and inclusion of patients between 6 and 18 years.;Timepoint(s) of evaluation of this end point: 1 year.	—

Measure

Time frame

Main Objective: The theme of this study is to characterize the genetic factors that influence the clearence of F VIII in patients with severe hemophilia A.;Secondary Objective: ;Primary end point(s): The major issue that we may face is an influence of age on FVIII PK. This effect is well documented, but is largely present in very young children (<5 years) and is minimized by employing an optimal blood sampling schedule and inclusion of patients between 6 and 18 years.;Timepoint(s) of evaluation of this end point: 1 year.

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Countries

Austria, Belgium, Canada

Outcome results

None listed

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