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Coagulation Factor

nonacog beta pegol for Hemophilia B (paradigm™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 when minimum 20 pups have reached at least 50 ed (up to 156 weeks); when minimum 40 pups have reached at least 100 ed (up to 208 weeks); at end of trial (up to 434 weeks)
Awards & highlights

paradigm™6 Trial Summary

This trial is investigating a new drug for patients with Haemophilia B who have not been treated before. The goal is to see if it is safe and effective.

Eligible Conditions
  • Hemophilia B
  • Congenital Hematological Disorder

paradigm™6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~when minimum 20 pups have reached at least 50 ed (up to 156 weeks); when minimum 40 pups have reached at least 100 ed (up to 208 weeks); at end of trial (up to 434 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and when minimum 20 pups have reached at least 50 ed (up to 156 weeks); when minimum 40 pups have reached at least 100 ed (up to 208 weeks); at end of trial (up to 434 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days)
Number of Participants With Incidence of Inhibitory Antibodies Against FIX (100 ED)
Number of Participants With Incidence of Inhibitory Antibodies Against FIX (At End of Trial)
Secondary outcome measures
Amount of Drug Administered to Treat a Bleeding Episode
FIX Activity at 30 Minutes (C30min)
FIX Trough Levels
+10 more

Side effects data

From 2022 Phase 3 trial • 54 Patients • NCT02141074
32%
Pyrexia
15%
Upper respiratory tract infection
15%
Nasopharyngitis
12%
Cough
9%
Rhinorrhoea
9%
Diarrhoea
9%
Ear infection
9%
Rash
9%
Viral infection
6%
Vomiting
6%
Factor IX inhibition
6%
Haemorrhage intracranial
6%
Otitis media
6%
Otitis media acute
3%
Skin laceration
3%
Anaphylactic reaction
3%
Pharyngitis
3%
Bronchitis
3%
Fall
3%
Influenza
3%
Conjunctivitis
3%
Drug hypersensitivity
3%
Tonsillitis
3%
Epistaxis
3%
Nasal congestion
3%
Teething
3%
Head injury
3%
Bronchiolitis
3%
Gastroenteritis salmonella
3%
Gastroenteritis viral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-prophylaxis
Prophylaxis

paradigm™6 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
nonacog beta pegol
2009
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,415,014 Total Patients Enrolled
54 Trials studying Hemophilia B
6,952 Patients Enrolled for Hemophilia B
Global Clinical Registry (GCR, 1452)Study DirectorNovo Nordisk A/S
778 Previous Clinical Trials
767,393 Total Patients Enrolled
40 Trials studying Hemophilia B
5,138 Patients Enrolled for Hemophilia B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Research and Practice in Thrombosis and HaemostasisJournal
Nonacog Beta Pegol (N9‐GP) in Hemophilia B: First Report on Safety and Efficacy in Previously Untreated and Minimally Treated Patients
Chan, Anthony K., Jayanthi Alamelu, Chris Barnes, Ampaiwan Chuansumrit, May‐Lill Garly, Rikke Medom Meldgaard, and Guy Young. 2020. “Nonacog Beta Pegol (N9‐GP) in Hemophilia B: First Report on Safety and Efficacy in Previously Untreated and Minimally Treated Patients”. Research and Practice in Thrombosis and Haemostasis. Wiley. doi:10.1002/rth2.12412.
clinicaltrials.govStudy
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
2014. "Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02141074.
~5 spots leftby Apr 2025
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