CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 71 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/NCT01395810
NCT01395810Phase 3Completed
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Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

Novo Nordisk A/S·interventional·Posted Jul 18, 2011·Updated May 9, 2018

In Brief

A Phase 3 clinical trial evaluating nonacog beta pegol for Congenital Bleeding Disorder and Haemophilia B. Completed, enrolled 71 participants across 49 sites in 18 countries.

Detailed Summary

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2011
Enrollment StartApr 15, 2012
Primary CompletionMar 30, 2014
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 15.0 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). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode.

nonacog beta pegoldrug

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