DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.

Information source: Bio Products Laboratory
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Von Willebrand Disease

Intervention: Optivate® (Human Coagulation Factor VIII) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Bio Products Laboratory

Summary

The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.

Clinical Details

Official title: An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.

Study design: Primary Purpose: Treatment

Primary outcome: PK parameters for FVIII:C

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity)

without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days. Exclusion Criteria:

-

Locations and Contacts

Klinika Haematologii, Akademia Medyczna w Gdansku, ul., Debinki 7, 80-211 Gdansk, Poland

Klinika Haematologii, Akademia Medyczna w Lublinie, ul., Dr K Jaczewskiego 8, 20-090, Lublin, Poland

Klinika Haematologii, Akademia Medyczna w Lodzi, ul., Pabianicka 62, 93-513 Lodz, Poland

Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard, Nottingham N67 2UH, United Kingdom

Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, United Kingdom

Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary, Manchester M13 9WL, United Kingdom

Haemophilia Centre, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, United Kingdom

Haemophilia Centre, Addenbrooke's Hospital, Hills Road, Cambridge, Cambridgeshire CB2 2QQ, United Kingdom

Additional Information

Starting date: October 2001
Last updated: September 19, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017