EUCTR2020-004344-28-DE
Active, Not Recruiting
Phase 1
CLINICAL STUDY TO INVESTIGATE THE EFFICACY, PHARMACOKINETICS, IMMUNOGENICITY AND SAFETY OF WILATE IN SEVERE VON WILLEBRAND DISEASE PATIENTS UNDER THE AGE OF 6 YEARS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Octapharma Pharmazeutika Produktionsges.m.b.H.
- Enrollment
- 12
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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 (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))
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •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
Exclusion Criteria
- •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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