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Clinical Trials/EUCTR2012-001669-34-AT
EUCTR2012-001669-34-AT
Active, not recruiting
Not Applicable

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

Med. Univ. Wien, Univ. Klinik f. Kinder- u. Jugendheilkunde, Klin. Abt.f. Pädiatrische Kardiologie0 sites100 target enrollmentJune 6, 2012
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ConditionsHaemophilia A under prophylactic Factor VIII SubstitutionTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsAdvateKogenateRefacto AFHelixate NexGen

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Haemophilia A under prophylactic Factor VIII Substitution
Sponsor
Med. Univ. Wien, Univ. Klinik f. Kinder- u. Jugendheilkunde, Klin. Abt.f. Pädiatrische Kardiologie
Enrollment
100
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 6, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Med. Univ. Wien, Univ. Klinik f. Kinder- u. Jugendheilkunde, Klin. Abt.f. Pädiatrische Kardiologie

Eligibility 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 \<1%). Only patients using recombinant FVIII products will be included. Following the acquisition of written informed consent the following investigations will be performed on the study participants
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 10
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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.

Outcomes

Primary Outcomes

Not specified

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