A Study With OPTIVATE® in People With Von Willebrand Disease | NCT00387192

Studies
A Study With OPTIVATE® in People With Von Willebrand Disease

NCT00387192

Sponsor

Bio Products Laboratory

Status

Terminated

Last Update Posted

Mar 3, 2010Estimated

Enrollment

26Estimated

Phase

Phase 3

Conditions

Von Willebrand Disease

Interventions

Optivate

Countries

Israel
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to slow recruitment and a significant delay in reaching the recruitment target.

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Sep 2008Actual

First Submitted Date

Oct 11, 2006

First Submission Date that Met QC Criteria

Oct 11, 2006

First Posted Date

Oct 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2010

Last Update Posted Date

Mar 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Name	Type	Description	Arm Group Labels	Other Names
Optivate	Drug	Plasma-derived Factor VIII

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus, 8 Haaliya St., Bat-Galim		Haifa		31096	Israel
Haddasah Ein-Karem Medical Center, P.O.Box 12000

ID	Term
D014842	von Willebrand Diseases
D006467	Hemophilia A

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases