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NCT03528551 · ClinicalTrials.gov registry record · Phase 3

A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A

A Phase 3 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
160
Enrollment target

NCT03528551 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 160 participants.

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The verdict

NCT03528551, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
160 participants
Enrollment target

Study Summary

This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.

Interventions

  • DRUG Turoctocog alfa pegol

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2018-04-30
Est. Completion 2020-12-03
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT03528551

The ClinicalTrials.gov registry entry for NCT03528551 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Turoctocog alfa pegol is the first listed.

NCT03528551 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03528551 about?

NCT03528551 is a clinical study titled "A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A". This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participant...

What is the current status of trial NCT03528551?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2018-04-30. Estimated completion is 2020-12-03.

What interventions are being tested in trial NCT03528551?

The interventions under investigation include: Turoctocog alfa pegol (DRUG).

Who is sponsoring clinical trial NCT03528551?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.