Trial record 5 of 32 for:
"Von Willebrand disease"
A Study With OPTIVATE® in People With Von Willebrand Disease
This study has been terminated.
(Due to slow recruitment and a significant delay in reaching the recruitment target.)
Information provided by:
Bio Products Laboratory
First received: October 11, 2006
Last updated: March 2, 2010
Last verified: March 2010
The main objective of the study is to assess the pharmacokinetics of OPTIVATE® after a single dose of 80 IU/kg VWF:RCo. The secondary objectives of the study are to assess efficacy and safety of OPTIVATE® in long-term use over at least 12 months.
Von Willebrand Disease
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open Multi-centre Study in Patients With Von Willebrand Disease to Investigate the Pharmacokinetics, Efficacy and Safety of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and Von Willebrand Factor Concentrate
Primary Outcome Measures:
- Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall. [ Time Frame: Baseline vist ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Have given written informed consent.
- Be aged 12 years or older.
- Have severe VWD (VWF:RCo <20%) of known type. Severity will be confirmed by a current VWF:RCo result of <20%.
- Be known or expected to require a concentrate for management of VWD.
- Must have had at least one bleed in the last 12 months which required treatment with a FVIII and VWF concentrate.
- Have a known lack of, or poor response to, DDAVP.
- Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range.
- At the Baseline Visit (Visit 1), patients must have had at least 5 days since their last infusion of replacement factor concentrate or DDAVP.
- Female patients of child-bearing potential must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female patient is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study. Female patients must not be lactating.
- Have a history of inhibitor development to VWF or FVIII or a positive result at screening.
- Actively bleeding (Note: the patient can enter the study once the bleed is controlled).
- Presence of major systemic illnesses: renal disease, liver disease, or neurological or psychiatric disease which would compromise the outcome of the study in the opinion of the investigator.
- Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
- Have a recent history of alcohol or drug abuse.
- Administration of a new chemical entity within the 4 months preceding enrolment.
- Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment into this study, with the exception of the BPL clinical study Protocol 8VWF03.
- In the opinion of the investigator, the patient is unlikely to comply with the study protocol.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387192
|Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
|Haifa, Israel, 31096 |
|Haddasah Ein-Karem Medical Center, P.O.Box 12000
|Jerusalem, Israel, 91120 |
|Beilinson Hospital, Rabin Medical Center, 39 Jabontinsky Street
|Petah Tikva, Israel, 49100 |
|University Department of Haematology
|Manchester, United Kingdom, M13 9WL |
Bio Products Laboratory
||Charles Hay, MD
||Manchester Haemophilia Comprehensive Care Centre
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 11, 2006
||March 2, 2010
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Bio Products Laboratory:
Von Willebrand Disease
Von Willebrand Factor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Coagulation Protein Disorders
Blood Platelet Disorders
Genetic Diseases, Inborn