NCT02250508

Brief Summary

The main objectives of the study were

  • to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays.
  • to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

September 2, 2014

Last Update Submit

February 14, 2018

Conditions

vonWillebrand's Disease

Outcome Measures

Primary Outcomes (1)

  • AUC (0-48h) for VWF: RCo

    Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose

Study Arms (2)

Optivate®

EXPERIMENTAL
Biological: Optivate® (Human Coagulation Factor VIII)

Haemate P®

ACTIVE COMPARATOR
Biological: Haemate P® (Human Coagulation Factor VIII)

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL
Optivate®
Haemate P® (Human Coagulation Factor VIII)BIOLOGICAL
Haemate P®

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology Dept., Sackler School of Medicine, Tel Aviv University

Tel Aviv, Israel

Location

Related Links

MeSH Terms

Interventions

optivateFactor VIIIfactor VIII, von Willebrand factor drug combination

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 26, 2014

Study Start

December 1, 2004

Primary Completion

June 1, 2005

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

IL(1)