Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

Completed · Phase 2 · Has a placebo group

Conditions studied: Acquired Bleeding Disorder, Bleeding During/Following Surgery

In brief

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.

Key facts

Study ID

NCT01562158

Run by

Novo Nordisk A/S

People needed

100

Starts

2001-04-01

Expected to finish

2003-10-01

Last updated by the study team

2017-01-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have undergone allogeneic or autologous stem cell transplantation

You may not qualify if…

• Known or suspected allergy to trial product
• Participation in other trials with unapproved drugs or trials with equal or similar objective

Where it is running

• Novo Nordisk Investigational Site — Chapel Hill, North Carolina, United States
• Novo Nordisk Investigational Site — Herston, Australia
• Novo Nordisk Investigational Site — Parkville, Australia
• Novo Nordisk Investigational Site — Westmead, Australia
• Novo Nordisk Investigational Site — Vienna, Austria
• Novo Nordisk Investigational Site — Copenhagen, Denmark
• Novo Nordisk Investigational Site — Helsinki, Finland
• Novo Nordisk Investigational Site — Besançon, France
• Novo Nordisk Investigational Site — Lille, France
• Novo Nordisk Investigational Site — Tours, France
• Novo Nordisk Investigational Site — Cologne, Germany
• Novo Nordisk Investigational Site — Dresden, Germany
• Novo Nordisk Investigational Site — Hamburg, Germany
• Novo Nordisk Investigational Site — Hanover, Germany
• Novo Nordisk Investigational Site — Idar-Oberstein, Germany
• Novo Nordisk Investigational Site — München, Germany
• Novo Nordisk Investigational Site — Regensburg, Germany
• Novo Nordisk Investigational Site — Tübingen, Germany
• Novo Nordisk Investigational Site — Wiesbaden, Germany
• Novo Nordisk Investigational Site — Haifa, Israel
• Novo Nordisk Investigational Site — Jerusalem, Israel
• Novo Nordisk Investigational Site — Florence, Italy
• Novo Nordisk Investigational Site — Genova, Italy
• Novo Nordisk Investigational Site — Pesaro, Italy
• Novo Nordisk Investigational Site — Rome, Italy

Full record on ClinicalTrials.gov

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