CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 13 enrolled
Drug / intervention
nonacog beta pegoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01386528
NCT01386528Phase 3Completed

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

Novo Nordisk A/S·interventional·Posted Jul 1, 2011·Updated Aug 23, 2017

In Brief

A Phase 3 clinical trial evaluating nonacog beta pegol for Congenital Bleeding Disorder and Haemophilia B. Completed, enrolled 13 participants across 41 sites in 17 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, North Macedonia, Romania, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2011
Enrollment StartJun 7, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.0 years ago

Interventions

nonacog beta pegoldrug

The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).