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Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A

NCT01811875 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-07-22

Study results available
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Summary

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

Conditions

  • Haemophilia A

Interventions

BIOLOGICAL

Optivate 500IU

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Principal Investigators

  • Eric Wolford · Bio Products Laboratory

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-21
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Colombia
  • Germany
  • Poland

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 NCT01811875 on ClinicalTrials.gov