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NCT01467427 · ClinicalTrials.gov registry record · Phase 3

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

A Phase 3 study of Congenital Bleeding Disorder and Haemophilia B, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
25
Enrollment target
20
Study locations

NCT01467427 is a Phase 3 study of Congenital Bleeding Disorder and Haemophilia B that has completed, run by Novo Nordisk A/S. The registered enrollment target is 25 participants, below the 136-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT01467427, a Phase 3 study of Congenital Bleeding Disorder and Haemophilia B, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
25 participants
Enrollment target
20
Study locations

Study Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

Interventions

  • DRUG nonacog beta pegol

Study Locations (20)

Ohio

  • Univ Hosp Cleveland Med Ctr - Cleveland
  • Nationwide Children's Hospital - Columbus
  • Dayton Children Hemostati Ctr - Dayton

California

  • Children's Hospital Los Angeles - Endocrinology - Los Angeles
  • UC Davis Medical Center - Sacramento

Georgia

  • Emory University_Atlanta_1 - Atlanta
  • Augusta University - Augusta

New York

  • Maimonides Medical Center - Brooklyn
  • Mount Sinai Medical Center - New York

Colorado

  • Colorado Hemophilia & Thrombosis Center - Aurora

District of Columbia

  • Childrens National Medical Ctr - Washington D.C.

Florida

  • University of Miami Hospital & Clinics - Miami

Iowa

  • University Of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2012-05-16
Est. Completion 2023-11-17
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT01467427

The ClinicalTrials.gov registry entry for NCT01467427 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 136-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (82% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Congenital Bleeding Disorder appearing as the primary indexed condition, and to 1 intervention - of which nonacog beta pegol is the first listed.

NCT01467427 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Ohio, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT01467427 about?

NCT01467427 is a clinical study titled "Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.". This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

What is the current status of trial NCT01467427?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2012-05-16. Estimated completion is 2023-11-17.

What conditions does trial NCT01467427 study?

This clinical trial studies the following conditions: Congenital Bleeding Disorder, Haemophilia B.

What interventions are being tested in trial NCT01467427?

The interventions under investigation include: nonacog beta pegol (DRUG).

Who is sponsoring clinical trial NCT01467427?

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

Where is trial NCT01467427 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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