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NCT01392547 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

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

Completed
Registry status
Phase 3
Development phase
72
Enrollment target
20
Study locations

NCT01392547 is a Phase 3 study of Congenital Bleeding Disorder and Haemophilia A With Inhibitors that has completed, run by Novo Nordisk A/S. The registered enrollment target is 72 participants, below the 130-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT01392547, a Phase 3 study of Congenital Bleeding Disorder and Haemophilia A With Inhibitors, has completed, sponsored by Novo Nordisk A/S.

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

Study Summary

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Interventions

  • DRUG vatreptacog alfa (activated)
  • DRUG eptacog alfa (activated)

Study Locations (20)

Other

  • - Linz
  • - Zagreb
  • - Athens
  • - Budapest
  • - Milan

California

  • Novo Nordisk Clinical Trial Call Center - Los Angeles
  • Novo Nordisk Clinical Trial Call Center - Los Angeles
  • Novo Nordisk Clinical Trial Call Center - Orange

Georgia

  • Novo Nordisk Clinical Trial Call Center - Atlanta
  • Novo Nordisk Clinical Trial Call Center - Augusta

Arizona

  • Novo Nordisk Clinical Trial Call Center - Tucson

Colorado

  • Novo Nordisk Clinical Trial Call Center - Aurora

Florida

  • Novo Nordisk Clinical Trial Call Center - Tampa

Iowa

  • Novo Nordisk Clinical Trial Call Center - Iowa City

Massachusetts

  • Novo Nordisk Clinical Trial Call Center - Boston

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2011-07
Est. Completion 2012-08
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT01392547

The ClinicalTrials.gov registry entry for NCT01392547 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (45% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Congenital Bleeding Disorder appearing as the primary indexed condition, and to 2 interventions - of which vatreptacog alfa (activated) is the first listed.

NCT01392547 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT01392547 about?

NCT01392547 is a clinical study titled "Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors". This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

What is the current status of trial NCT01392547?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2011-07. Estimated completion is 2012-08.

What conditions does trial NCT01392547 study?

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

What interventions are being tested in trial NCT01392547?

The interventions under investigation include: vatreptacog alfa (activated) (DRUG), eptacog alfa (activated) (DRUG).

Who is sponsoring clinical trial NCT01392547?

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

Where is trial NCT01392547 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, 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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