Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
NCT01489111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-08-10
Summary
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
Conditions
- Congenital Bleeding Disorder
- Haemophilia A
Interventions
- DRUG
-
turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-03
- Primary Completion
- 2018-12-10
- Completion
- 2018-12-10
Countries
- United States
- Australia
- Brazil
- Bulgaria
- Croatia
- Denmark
- France
- Germany
- Hungary
- Israel
- Italy
- Japan
- Malaysia
- Netherlands
- Norway
- Spain
- Sweden
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
NCT00984126 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A
NCT02994407 ·Status: COMPLETED ·Phase: PHASE1
-
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
NCT02920398 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A
NCT02035384 ·Status: COMPLETED
-
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
NCT01731600 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
NCT03528551 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
NCT01138501 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
NCT02938585 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
NCT03588741 ·Status: TERMINATED ·Phase: PHASE3
-
A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
NCT03196297 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
NCT02137850 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
NCT01333111 ·Status: COMPLETED ·Phase: PHASE3
-
Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A
NCT01692925 ·Status: COMPLETED ·Phase: PHASE1
-
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
NCT04682145 ·Status: ENROLLING_BY_INVITATION
-
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
NCT01392547 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)
NCT05082116 ·Status: COMPLETED ·Phase: PHASE3
-
A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A
NCT01365520 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
NCT01395810 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
NCT02941354 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
NCT01467427 ·Status: COMPLETED ·Phase: PHASE3
-
Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients
NCT06574984 ·Status: RECRUITING
-
Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities
NCT04584892 ·Status: COMPLETED
-
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors
NCT04083781 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors
NCT04082429 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
NCT01454739 ·Status: COMPLETED ·Phase: PHASE3