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

NCT01731600 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 68 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) ≥0.6 Bethesda units was presented.

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
Novo Nordisk A/S

431 total trials

What the finished NCT01731600 record still lists

NCT01731600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

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

NCT01731600 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01731600's enrollment target sits among peer trials

68 1796th of 2000 higher than 205 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01731600, the US trial registry maintained by the National Library of Medicine. NCT01731600 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.