Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A

This study is not yet open for participant recruitment.
Verified March 2013 by Bio Products Laboratory
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory
ClinicalTrials.gov Identifier:
NCT01811875
First received: March 13, 2013
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma inhibitor levels for at least 100 Exposure Days (EDs) for each subject.

Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and adverse events


Condition Intervention Phase
Haemophilia A
Biological: Optivate 500IU
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A

Resource links provided by NLM:


Further study details as provided by Bio Products Laboratory:

Primary Outcome Measures:
  • To assess post-marketing immunogenicity of Optivate by monitoring plasma inhibitor levels for at least 100 Exposure Days for each subject. [ Time Frame: At least 100 Exposure Days for each subject. Subjects will attend 5 visits over a period of up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess efficacy and tolerability [ Time Frame: Over a period of 12 months ] [ Designated as safety issue: Yes ]

Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optivate 500IU
Optivate 500IU
Biological: Optivate 500IU

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent or, if less than 18 years of age written assent (where possible) and their parent/guardian's written informed consent.
  • Severe haemophilia A (< 1%# FVIII:C).
  • Previously Treated Patients (PTPs) with > 150 exposure days on prior Factor VIII therapy (of which at least the last 50 EDs or 2 years treatment can be confirmed by way of subject records).
  • Immunocompetent with CD4 count > 200 / µl.
  • HIV negative or a viral load < 200 particles / µl.

    • subjects suffering from severe haemophilia A (<2%) may be enrolled, but only after approval by BPL. Subjects with a Factor VIII of <2% may not constitute more than 50% of the total patient population. A separate statistical evaluation will be conducted for the <1% and <2% populations.

Exclusion Criteria:

  • • History of inhibitor development to FVIII or a positive result on the Nijmegen Bethesda at screening (quantitative result of > 0.6 BU) prior to the administration of Optivate®.

    • Known or suspected hypersensitivity to the investigational medicinal product or its excipients.
    • Clinically significant liver disease, renal disease, or coagulopathy other than haemophilia A.
    • History of unreliability or non cooperation (including not being able to complete the study diary).
    • Participating in, or have taken part in another trial within the last 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811875

Contacts
Contact: Tim Aldwinckle, Dr +44(0) 208 957 2200 tim.aldwinckle@bpl.co.uk

Locations
Germany
To be assigned Not yet recruiting
To be assigned, Germany
Contact: To be assigned         
Sponsors and Collaborators
Bio Products Laboratory
  More Information

No publications provided

Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT01811875     History of Changes
Other Study ID Numbers: 8VWF07
Study First Received: March 13, 2013
Last Updated: March 18, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Bio Products Laboratory:
Haemophilia A

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014