At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 54 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.
An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)
In Brief
A Phase 3 clinical trial evaluating nonacog beta pegol for Congenital Bleeding Disorder and Haemophilia B. Completed, enrolled 54 participants across 93 sites in 24 countries.
Detailed Summary
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia B
CountriesAlgeria, Argentina, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, Romania, Serbia, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartJul 2014
Primary CompletionOct 2022
TodayJul 2026
First PostedMay 19, 2014
Enrollment StartJul 2, 2014
Primary CompletionOct 27, 2022
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 12.1 years ago
Interventions
nonacog beta pegoldrug
For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.