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Clinical Trials/EUCTR2018-003869-33-NL
EUCTR2018-003869-33-NL
Active, not recruiting
Phase 1

Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients. - OPTI-CLOT: TARGET

Erasmus University Medical Center0 sites50 target enrollmentDecember 20, 2018
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ConditionsHemophiliaMedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsAdvateKogenate BayerHelixate NexGenReFacto AFAafactOctanateNovoEightIbliasKovaltryEloctaNuwiqAfstylaAdynovate or AdynoviImmunineMononineNonafactRixubis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hemophilia
Sponsor
Erasmus University Medical Center
Enrollment
50
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 20, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Hemophilia A and B patients of all ages on prophylaxis;
  • •\-Prophylaxis with SHL factor concentrate or EHL factor concentrate;
  • •\-Written (parental) informed consent, according to local law and regulations
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 25
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 20
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 5

Exclusion Criteria

  • •\-Patients with other congenital or acquired hemostatic abnormalities;
  • •\-General medical conditions which may interfere with participation in the study;
  • •\-Inability to adhere to prophylaxis and/ or inability to keep detailed logs of infusions and bleeding episodes;
  • •\-Withdrawal of (parental) informed consent.

Outcomes

Primary Outcomes

Not specified

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