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NCT01731600 · ClinicalTrials.gov registry record · Phase 3

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

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

Completed
Registry status
Phase 3
Development phase
68
Enrollment target

NCT01731600 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 68 participants.

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The verdict

NCT01731600, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
68 participants
Enrollment target

Study Summary

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

Interventions

  • DRUG turoctocog alfa pegol

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2013-02-20
Est. Completion 2018-09-28
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT01731600

The ClinicalTrials.gov registry entry for NCT01731600 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 68 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.

NCT01731600 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01731600 about?

NCT01731600 is a clinical study titled "A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A". This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

What is the current status of trial NCT01731600?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2013-02-20. Estimated completion is 2018-09-28.

What interventions are being tested in trial NCT01731600?

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

Who is sponsoring clinical trial NCT01731600?

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.