CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 74 enrolled
Drug / intervention
nonacog beta pegol +2 moredrug
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/NCT01333111
NCT01333111Phase 3Completed
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A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

Novo Nordisk A/S·interventional·Posted Apr 11, 2011·Updated Jul 28, 2017

In Brief

A Phase 3 clinical trial evaluating nonacog beta pegol for Congenital Bleeding Disorder and Haemophilia B. Completed, enrolled 74 participants across 43 sites in 15 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia B
CountriesCanada, France, Germany, Hungary, Italy, Japan, Malaysia, Netherlands, North Macedonia, Russia, South Africa, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2011
Enrollment StartApr 27, 2011
Primary CompletionMar 31, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.2 years ago

Interventions

nonacog beta pegoldrug

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

nonacog beta pegoldrug

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

nonacog beta pegoldrug

Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode