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Clinical Trials/ISRCTN11217735
ISRCTN11217735
Active, not recruiting
Phase 3

Clinical study to investigate the efficacy, pharmacokinetics, immunogenicity and safety of wilate in severe von Willebrand disease patients under the age of 6 years

Octapharma (Austria)0 sites12 target enrollmentAugust 23, 2021
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Octapharma (Austria)
Enrollment
12
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 23, 2021
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Octapharma (Austria)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients aged \<6 years at the time of screening
  • •2\. Type 3 (at least four patients), severe type 2 (except 2N) or severe type 1 VWD (and of which with VWF:RCo \<20%) according to medical history, requiring substitution therapy with a VWF\-containing product
  • •3\. Minimum body weight 12\.5 kg at the time of screening
  • •4\. Voluntarily given, fully informed written and signed consent obtained before any study\-related procedures are conducted (obtained from the patient’s parent(s)/legal guardian(s))

Exclusion Criteria

  • •1\. History, or current suspicion of VWF or FVIII inhibitors
  • •2\. Injection of DDAVP or VWF\-containing product within 72 hours prior to inclusion
  • •3\. Medical history of a thromboembolic event
  • •4\. Platelet count \<100,000/µl at screening (except for VWD type 2B)
  • •5\. Patients receiving, or scheduled to receive, immunosuppressant drugs (other than antiretroviral chemotherapy), such as prednisone (equivalent to \>10 mg/day), or similar drugs
  • •6\. Treatment with any investigational medicinal product (IMP) in another interventional clinical study currently or within four weeks before enrolment
  • •7\. Other coagulation disorders or bleeding disorders
  • •8\. Known hypersensitivity to any of the components of the study drug

Outcomes

Primary Outcomes

Not specified

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