|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
19 March 2012 |
|
Main ID: |
EUCTR2006-002857-54-DE |
|
Date of registration:
|
10/08/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD)
|
|
Scientific title:
|
International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD) |
|
Date of first enrolment:
|
10/11/2006 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002857-54 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Patients with defined inherited vWD of any type, not responding to DDAVP treatment, who need treatment with plasma derived vWF may be included. Age > 6 and < 85 years. Patients who did not receive other plasma derived or blood products 72 hours before treatment with WILOCTIN, who did not receive DDAVP 15 days or acetylsalicylic acid 7 days before treatment. Patients without severe liver or kidney disease.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Administration of other plasma derived or blood product 72 hours before treatment.
Administration of DDAVP 15 days before treatment.
Administration of acetylsalicylic acid 7 days before treatment.
Known history of intolerance versus plasma derived or blood products.
Symptomatic infection.
Severe liver or kidney disease (ALAT 5x > normal value, creatinine > 120 µmol/l).
Participation in another clinical study currently or during the past four weeks.
Pregnancy or lactating women.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
von Willebrand Jürgends syndrom in children under 6 years of age
|
|
Intervention(s)
|
Trade Name: WILATE
Product Name: Wiloctin
Pharmaceutical Form:
|
|
Primary Outcome(s)
|
|
Secondary Objective: Secondary objectives are to measure bleeding time (BT); to assess overall efficacy and safety and tolerability of WILOCTIN.
|
|
Main Objective: The primary objective of this study is to confirm the clinical efficacy of WILOCTIN using surrogate markers, i.e. the plasma levels of FVIII:C, vWF:Ag, vWF:CBA and vWF:RCoF before and after administration.
|
|
Primary end point(s): Plasma levels of FVIII:C, vWF:Ag, vWF:CBA and vWF:RCoF are the primary endpoints and will be measured as predefined time-points.
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|