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Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ

NCT02962765 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2021-10-21

Study results available
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Summary

Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

Conditions

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Kate Khair, PhD · Great Ormond Street Hospital

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2020-08-20
Completion
2020-08-20

Countries

  • United States
  • Argentina
  • Belarus
  • Czechia
  • Ecuador
  • France
  • Guatemala
  • Italy
  • Lithuania
  • Norway
  • Portugal
  • Slovakia
  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT02962765 on ClinicalTrials.gov