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

NCT02246881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-02-15

No results posted yet for this study

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.

Conditions

  • Von Willebrand Disease

Interventions

BIOLOGICAL

Optivate® (Human Coagulation Factor VIII)

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Study Design

Purpose
TREATMENT

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2004-01-31

Countries

  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246881 on ClinicalTrials.gov