Clinical trial

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated…

NCT02141074 · Novo Nordisk A/S, Industry · Completed

Key facts

NCT number NCT02141074
Title Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
Official title An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)
Acronym paradigm™6
Lead sponsor Novo Nordisk A/S, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Congenital Bleeding Disorder, Haemophilia B
Intervention type Drug
Interventions nonacog beta pegol
Enrollment 54
Start date Jul 2, 2014
Primary completion Oct 27, 2022
Completion Oct 27, 2022
First posted May 19, 2014
Last update posted Dec 23, 2025
Countries Algeria, Argentina, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Japan and 12 more

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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