A Study With OPTIVATE® in People With Von Willebrand Disease

March 2, 2010 updated by: Bio Products Laboratory

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus, 8 Haaliya St., Bat-Galim
      • Jerusalem, Israel, 91120
        • Haddasah Ein-Karem Medical Center, P.O.Box 12000
      • Petah Tikva, Israel, 49100
        • Beilinson Hospital, Rabin Medical Center, 39 Jabontinsky Street
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • University Department of Haematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall.
Time Frame: Baseline vist
Baseline vist

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio Products Laboratory

Investigators

  • Principal Investigator: Charles Hay, MD, Manchester Haemophilia Comprehensive Care Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 12, 2006

Study Record Updates

Last Update Posted (Estimate)

March 3, 2010

Last Update Submitted That Met QC Criteria

March 2, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8VWF01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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