← Back to Search

Coagulation Factor

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A (pathfinder™6 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of the treatment up to 8.9 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is for a new haemophilia A treatment. It is investigating how safe and effective it is in patients who have not been treated before.

Eligible Conditions
  • Congenital Hematological Disorder
  • Hemophilia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of the treatment up to 8.9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of the treatment up to 8.9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII)
Secondary study objectives
Consumption of N8-GP for Prophylaxis (International Unit Per Kilogram (IU/Kg))
Consumption of N8-GP for Prophylaxis (Number of Injections)
Consumption of N8-GP for Treatment of Bleeding Episodes (International Unit Per Kilogram Per Bleed (IU/kg/Bleed))
+7 more

Side effects data

From 2023 Phase 3 trial • 124 Patients • NCT02137850
38%
Pyrexia
32%
Nasopharyngitis
23%
Upper respiratory tract infection
17%
Factor VIII inhibition
13%
Ear infection
13%
Cough
13%
Gastroenteritis
10%
Rhinorrhoea
9%
Diarrhoea
9%
Influenza
9%
Tonsillitis
9%
Bronchitis
7%
Conjunctivitis
7%
Contusion
7%
Pharyngitis
7%
Rhinitis
7%
Viral infection
7%
Vomiting
6%
Otitis media
6%
Pharyngotonsillitis
4%
Hand-foot-and-mouth disease
3%
Varicella
3%
Anti factor VIII antibody positive
1%
Seizure
1%
Cerebral haemorrhage
1%
Anaemia
1%
Catheter site infection
1%
Delirium
1%
Enterobacter infection
1%
Pneumonia haemophilus
1%
Rash erythematous
1%
Toxicity to various agents
1%
Tracheitis
1%
Urogenital fistula repair
1%
Varicella zoster virus infection
1%
Tongue injury
1%
Vascular device infection
1%
Wound
1%
Tooth extraction
1%
Cellulitis
1%
Urethral repair
1%
Wound haemorrhage
1%
Pneumonia
1%
Sepsis
1%
Tooth injury
1%
Tracheobronchitis
1%
Tooth loss
1%
Dermatitis diaper
1%
Respiratory failure
1%
Head injury
1%
Post procedural fistula
1%
Respiratory syncytial virus infection
1%
Tonsillar hypertrophy
1%
Traumatic haematoma
1%
Arteriovenous fistula operation
1%
Tooth fracture
1%
Angioedema
1%
Therapy non-responder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylaxis
Immune Tolerance Induction (ITI)
Pre-prophylaxis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 50 EDs (exposure days)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
turoctocog alfa pegol
2012
Completed Phase 3
~520

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,559 Previous Clinical Trials
3,646,283 Total Patients Enrolled
1 Trials studying Hemophilia
3,000 Patients Enrolled for Hemophilia
Global Clinical Registry (GCR, 1452)Study DirectorNovo Nordisk A/S
778 Previous Clinical Trials
767,322 Total Patients Enrolled
~11 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top