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

This study has been terminated.
(The study was a post-marketing commitment requested by the PEI and is no longer required as the Optivate German license will be allowed to expire in Sep-2017.)
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory
ClinicalTrials.gov Identifier:
NCT01811875
First received: March 13, 2013
Last updated: July 12, 2017
Last verified: July 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]

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

Enrollment: 6
Study Start Date: June 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optivate 500IU
Optivate 500IU
Biological: Optivate 500IU

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811875

Locations
Colombia
Fundacion BIOS
Barranquilla, Colombia, 80-216
Hospital general de Medellin
Medellin, Colombia, 32-102
Germany
HZRM Haemophilia Centre Rhine Main
Moerfelden-Walldorf, Hessen, Germany, 64546
Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, Poland, 93-513
Sponsors and Collaborators
Bio Products Laboratory
Investigators
Study Director: Eric Wolford Bio Products Laboratory
  More Information

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: July 12, 2017

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

ClinicalTrials.gov processed this record on July 27, 2017