NCT02250482

Brief Summary

The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

8 active sites

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

November 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
11.1 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

1.7 years

First QC Date

September 2, 2014

Last Update Submit

February 14, 2018

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

  • Incremental Recovery for plasma Factor VIII

    Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG

    90 minutes after pre-operative bolus dose

Study Arms (1)

Optivate®

EXPERIMENTAL

Optivate® (Human Coagulation Factor VIII)

Biological: Optivate® (Human Coagulation Factor VIII)

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL
Optivate®

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Klinika Haematologii, Akademia Medyczna w Gdansku, ul.

Debinki 7, 80-211 Gdansk, Poland

Location

Klinika Haematologii, Akademia Medyczna w Lublinie, ul.

Dr K Jaczewskiego 8, 20-090, Lublin, Poland

Location

Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.

Szkolna 8/12, 61-833 Poznan, Poland

Location

Haemophilia Centre, Addenbrooke's Hospital, Hills Road

Cambridge, CB2 2QQ, United Kingdom

Location

Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard

Nottingham, N67 2UH, United Kingdom

Location

Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road

Sheffield, S10 2JF, United Kingdom

Location

Haemophilia Centre, Southampton General Hospital, Tremona Road

Southampton, SO16 6YD, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hemophilia A

Interventions

optivateFactor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 26, 2014

Study Start

November 1, 2001

Primary Completion

August 1, 2003

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

PL(3)GB(5)