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NCT01561937 · ClinicalTrials.gov registry record · Phase 1

Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment

A Phase 1 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 1
Development phase
127
Enrollment target

NCT01561937: Completed Phase 1 study, sponsored by Novo Nordisk A/S.

NCT01561937 is a Phase 1 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01561937, a Phase 1 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 1
Development phase
127 participants
Enrollment target

Study Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).

Interventions

  • DRUG placebo
  • DRUG warfarin
  • DRUG eptacog alfa (activated)

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2007-01
Est. Completion 2008-07
Phase Phase 1
Novo Nordisk A/S

431 total trials

What the finished NCT01561937 record still lists

NCT01561937 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT01561937 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01561937 about?

NCT01561937 is a clinical study titled "Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment". This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Rati...

What is the current status of trial NCT01561937?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2007-01. Estimated completion is 2008-07.

What interventions are being tested in trial NCT01561937?

The interventions under investigation include: placebo (DRUG), warfarin (DRUG), eptacog alfa (activated) (DRUG).

Who is sponsoring clinical trial NCT01561937?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01561937's enrollment target sits among peer trials

127 459th of 2000 higher than 1,540 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01561937, the US trial registry maintained by the National Library of Medicine. NCT01561937 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.