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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387192
First Posted: October 12, 2006
Last Update Posted: March 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bio Products Laboratory
October 11, 2006
October 12, 2006
March 3, 2010
November 2006
Not Provided
Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall. [ Time Frame: Baseline vist ]
Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall.
Complete list of historical versions of study NCT00387192 on ClinicalTrials.gov Archive Site
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A Study With OPTIVATE® in People With Von Willebrand Disease
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Von Willebrand Disease
Drug: Optivate
Plasma-derived Factor VIII
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
September 2008
Not Provided

Inclusion Criteria:

  1. Have given written informed consent.
  2. Be aged 12 years or older.
  3. Have severe VWD (VWF:RCo <20%) of known type. Severity will be confirmed by a current VWF:RCo result of <20%.
  4. Be known or expected to require a concentrate for management of VWD.
  5. Must have had at least one bleed in the last 12 months which required treatment with a FVIII and VWF concentrate.
  6. Have a known lack of, or poor response to, DDAVP.
  7. Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range.
  8. At the Baseline Visit (Visit 1), patients must have had at least 5 days since their last infusion of replacement factor concentrate or DDAVP.
  9. 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.

Exclusion Criteria:

  1. Have a history of inhibitor development to VWF or FVIII or a positive result at screening.
  2. Actively bleeding (Note: the patient can enter the study once the bleed is controlled).
  3. 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.
  4. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
  5. Have a recent history of alcohol or drug abuse.
  6. Administration of a new chemical entity within the 4 months preceding enrolment.
  7. 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.
  8. In the opinion of the investigator, the patient is unlikely to comply with the study protocol.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel,   United Kingdom
 
 
NCT00387192
8VWF01
No
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Bio Products Laboratory
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Principal Investigator: Charles Hay, MD Manchester Haemophilia Comprehensive Care Centre
Bio Products Laboratory
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP