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Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

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

NCT02137850•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 6 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•Male, age below 6 years of age at the time of signing informed consent
•Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results
•No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable)

Exclusion Criteria

•Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products
•Previous participation in this trial. Participation is defined as first dose administered of trial product
•Receipt of any investigational medicinal product within 30 days before screening
•Congenital or acquired coagulation disorder other than haemophilia A
•Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
•Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation

Locations (96)

Arizona H&T Phoenix Child Hosp

Phoenix, Arizona, United States

Miller Children's Hospital Long Beach

Long Beach, California, United States

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States

Children's Hosp Of Orange

Orange, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, United States

Nemours Child Orlando Hem/Onc

Orlando, Florida, United States

St Joseph's Hospital Foundation

Tampa, Florida, United States

Emory University_Atlanta_1

Atlanta, Georgia, United States

Key Dates

Start Date

June 26, 2014

Primary Completion Date

June 7, 2023

Completion Date

June 7, 2023

Last Updated

December 23, 2025

Enrollment

124

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia A

Interventions

turoctocog alfa pegol

DRUG

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

NCT06285071

Haemophilia AHaemophilia B

View study

ENROLLING_BY_INVITATION

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

NCT06831734

Haemophilia A, Haemophilia B

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

Inclusion Criteria

Exclusion Criteria

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

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