Surveillance of Efficacy and Tolerability in Von Willebrand's disease
| ISRCTN | ISRCTN63533506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63533506 |
| Secondary identifying numbers | WIL-15 |
- Submission date
- 18/11/2008
- Registration date
- 19/11/2008
- Last edited
- 07/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Jennifer Feddern
Scientific
Scientific
Octapharma GmbH
Langenfeld
40764
Germany
| jennifer.feddern@octapharma.de |
Study information
| Study design | Non-interventional, observational, open, prospective, multi-centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | Wilate-SET |
| Study objectives | The efficacy of Wilate® in clinical practice is comparable to the efficacy in clinical trial patients. As of 07/05/2011 the anticipated end date for this trial has been extended from 31/07/2009 to 31/07/2012 |
| Ethics approval(s) | As the procedures during this observational study do not interfere with the patient's usual treatment and monitoring of treatment, this study is not regarded as a clinical study as defined by EU Directive 2001/20/EC. Therefore approval by an Independent Ethical Committee as an Institutional Review Board is not required. |
| Health condition(s) or problem(s) studied | Von Willebrand's disease |
| Intervention | Documentation of details of diagnosis and bleeding frequency at entry, details of bleeding episodes and surgical procedures during 2-year individual observation period. Documentation of details of each injection including assessment of efficacy and tolerability at a 4-point verbal rating scale. Documentation of relevant laboratory assessments if performed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Wilate® |
| Primary outcome measure | Percentage of efficacy assessments with rating "excellent/good". |
| Secondary outcome measures | Percentage of tolerability assessments with rating "excellent/good". |
| Overall study start date | 01/02/2005 |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | At least 30 patients |
| Key inclusion criteria | Patients (any age and gender) suffering from hereditary or acquired Von Willebrand's disease requiring von Willebrand factor (VWF)/coagulation factor eight (FVIII) concentrate. |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Octapharma GmbH
Langenfeld
40764
Germany
40764
Germany
Sponsor information
Octapharma GmbH (Germany)
Industry
Industry
Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany
| VWS@octapharma.de | |
"ROR" |
https://ror.org/002k5fe57 |
Funders
Funder type
Industry
Octapharma GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
