Nonacog Beta Pegol for Hemophilia B
(paradigm™5 Trial)
Recruiting at74 trial locations
Age: < 18
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Novo Nordisk A/S
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.
Research Team
Eligibility Criteria
Inclusion Criteria
Men with a serious type of inherited bleeding disorder called hemophilia B and have very low levels of Factor IX in their blood.
You have used other FIX products for at least 50 days in the past.
Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)
See 2 more
Exclusion Criteria
You have a blood clotting disorder that is not hemophilia B.
You are taking medications that affect the immune system or are used to treat cancer, except for certain types of steroids.
You have had a heart attack or stroke in the past.
See 6 more
Treatment Details
Interventions
- nonacog beta pegol (Coagulation Factor)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: NNC-0156-000-0009Experimental Treatment1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen