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NCT01230021 · ClinicalTrials.gov registry record · Phase 3

Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency

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

Completed
Registry status
Phase 3
Development phase
6
Enrollment target

NCT01230021 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 6 participants.

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The verdict

NCT01230021, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
6 participants
Enrollment target

Study Summary

This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.

Interventions

  • DRUG catridecacog

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2010-11
Est. Completion 2012-01
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT01230021

The ClinicalTrials.gov registry entry for NCT01230021 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 6 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 catridecacog is the first listed.

NCT01230021 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01230021 about?

NCT01230021 is a clinical study titled "Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency". This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children ...

What is the current status of trial NCT01230021?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2010-11. Estimated completion is 2012-01.

What interventions are being tested in trial NCT01230021?

The interventions under investigation include: catridecacog (DRUG).

Who is sponsoring clinical trial NCT01230021?

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.