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NCT01395810 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
NCT01395810: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT01395810 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 71 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01395810, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
Study Summary
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).
Primary Outcome
The primary endpoint was incidence of inhibitors against coagulation factor nine (FIX) defined as titre ≥0.6 Bethesda unit (BU). Number of subjects who developed inhibitors against FIX are reported.
Interventions
- DRUG nonacog beta pegol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2012-04-15 |
| Est. Completion | 2014-03-30 |
| Phase | Phase 3 |
What the finished NCT01395810 record still lists
NCT01395810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which nonacog beta pegol is the first listed.
NCT01395810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01395810 about?
NCT01395810 is a clinical study titled "Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773". This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ ...
What is the current status of trial NCT01395810?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2012-04-15. Estimated completion is 2014-03-30.
What interventions are being tested in trial NCT01395810?
The interventions under investigation include: nonacog beta pegol (DRUG).
Who is sponsoring clinical trial NCT01395810?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01395810's enrollment target sits among peer trials
71 1784th of 2000 higher than 216 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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