CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 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/NCT01731600
NCT01731600Phase 3Completed
CompareCT.gov

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Novo Nordisk A/S·interventional·Posted Nov 22, 2012·Updated Nov 23, 2020

In Brief

A Phase 3 clinical trial evaluating turoctocog alfa pegol for Congenital Bleeding Disorder and Haemophilia A. Completed, enrolled 68 participants across 51 sites in 16 countries.

Detailed Summary

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A
CountriesBrazil, Canada, France, Greece, Israel, Italy, Japan, Lithuania, Malaysia, Portugal, Puerto Rico, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 22, 2012
Enrollment StartFeb 20, 2013
Primary CompletionSep 15, 2014
Study CompletionSep 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.6 years ago

Interventions

turoctocog alfa pegoldrug

Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.