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NCT02962765 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Octapharma.

Completed
Registry status
80
Enrollment target

NCT02962765: Completed study, sponsored by Octapharma.

NCT02962765 is a clinical trial that has completed, run by Octapharma. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02962765 has completed, sponsored by Octapharma.

COMPLETED
Registry status
80 participants
Enrollment target

Study 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.

Primary Outcome

FVIII inhibitors will be determined based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2015-01
Est. Completion 2020-08-20
Octapharma

43 total trials

What the finished NCT02962765 record still lists

NCT02962765 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02962765 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02962765 about?

NCT02962765 is a clinical study titled "Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ". 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. ...

What is the current status of trial NCT02962765?

This trial is currently completed. The enrollment target is 80 participants. The study started on 2015-01. Estimated completion is 2020-08-20.

Who is sponsoring clinical trial NCT02962765?

This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02962765, the US trial registry maintained by the National Library of Medicine. NCT02962765 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.