EUCTR2020-004344-28-CZ
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
- Routine prophylaxis in children under the age of 6 years with severe VWD
- Sponsor
- Octapharma Pharmazeutika Produktionsges.m.b.H.
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 2 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 (any of which with VWF:RCo \<20%) according to medical history, requiring substitution therapy with a VWF\-containing product
- •3\. Minimum body weight 11\.0 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
Similar Trials
Active, not recruiting
Phase 1
Clinical study to find out how well wilate works in little children with severe von Willebrand diseaseEUCTR2020-004344-28-DEOctapharma Pharmazeutika Produktionsges.m.b.H.12
Active, not recruiting
Phase 3
Clinical study to assess how well wilate works in the regular treatment of young children with severe von Willebrand diseaseISRCTN11217735Octapharma (Austria)12
Completed
Not Applicable
Clinical study to evaluate the efficacy, pharmacokinetics and safety of immunoglobulin intravenous (human) 10% (NewGam) in patients with primary immunodeficiency diseasesPrimary immunodeficiency diseases (PID)Haematological DisordersCommon variable immunodeficiencyISRCTN05425999Octapharma AG (Switzerland)50
Active, not recruiting
Not Applicable
Study to evaluate the efficacy, metabolism and safety of human immune globulin in patients with primary immunodeficiency diseases.EUCTR2009-011434-10-Outside-EU/EEAOCTAPHARMA AG51
Active, not recruiting
Not Applicable
CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASESEUCTR2009-011434-10-DEOCTAPHARMA AG50