CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 124 enrolled
Drug / intervention
turoctocog alfa 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/NCT02137850
NCT02137850Phase 3Completed
CompareCT.gov

An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A

Novo Nordisk A/S·interventional·Posted May 14, 2014·Updated Dec 23, 2025

In Brief

A Phase 3 clinical trial evaluating turoctocog alfa pegol for Congenital Bleeding Disorder and Haemophilia A. Completed, enrolled 124 participants across 96 sites in 23 countries.

Detailed Summary

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A
CountriesAlgeria, Argentina, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Mexico, Portugal, Puerto Rico, Romania, Serbia, Spain, Taiwan, Thailand, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 14, 2014
Enrollment StartJun 26, 2014
Primary CompletionJun 7, 2023
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 12.1 years ago

Interventions

turoctocog alfa pegoldrug

For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis