Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by:
Bio Products Laboratory
ClinicalTrials.gov Identifier:
NCT00387192
First received: October 11, 2006
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Von Willebrand Disease
Drug: Optivate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bio Products Laboratory:

Primary Outcome Measures:
  • Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall. [ Time Frame: Baseline vist ]

Estimated Enrollment: 26
Study Start Date: November 2006
Study Completion Date: September 2008
Intervention Details:
    Drug: Optivate
    Plasma-derived Factor VIII
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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

Locations
Israel
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
United Kingdom
University Department of Haematology
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Bio Products Laboratory
Investigators
Principal Investigator: Charles Hay, MD Manchester Haemophilia Comprehensive Care Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00387192     History of Changes
Other Study ID Numbers: 8VWF01
Study First Received: October 11, 2006
Last Updated: March 2, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bio Products Laboratory:
Von Willebrand Disease
Factor VIII
Von Willebrand Factor
Pharmacokinetics

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014