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

Acquired Bleeding Disorder Clinical Trial

Official title:

A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562158
• Other study ID #: F7BMT-1360
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2012
• Last updated: January 10, 2017
• Start date: April 2001
• Est. completion date: October 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyUnited Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)Israel: Ministry of HealthItaly: AIFA, National Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients who have undergone allogeneic or autologous stem cell transplantation

Exclusion Criteria:

• Known or suspected allergy to trial product

• Participation in other trials with unapproved drugs or trials with equal or similar objective

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Bleeding During/Following Surgery
• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders

Intervention

Procedure:
• standard therapy
Standard treatment of bleeding

Drug:
• activated recombinant human factor VII
Two days repeated treatment regimen - low dose administered i.v. (into the vein)
• activated recombinant human factor VII
Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
• activated recombinant human factor VII
Two days repeated treatment regimen - high dose administered i.v. (into the vein)
• placebo
Placebo

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Herston
Australia	Novo Nordisk Investigational Site	Parkville
Australia	Novo Nordisk Investigational Site	Westmead
Austria	Novo Nordisk Investigational Site	Vienna
Denmark	Novo Nordisk Investigational Site	København
Finland	Novo Nordisk Investigational Site	Helsinki
France	Novo Nordisk Investigational Site	Besancon
France	Novo Nordisk Investigational Site	Lille
France	Novo Nordisk Investigational Site	Tours
Germany	Novo Nordisk Investigational Site	Dresden
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Hannover
Germany	Novo Nordisk Investigational Site	Idar-Oberstein
Germany	Novo Nordisk Investigational Site	Köln
Germany	Novo Nordisk Investigational Site	München
Germany	Novo Nordisk Investigational Site	Regensburg
Germany	Novo Nordisk Investigational Site	Tübingen
Germany	Novo Nordisk Investigational Site	Wiesbaden
Israel	Novo Nordisk Investigational Site	Haifa
Israel	Novo Nordisk Investigational Site	Jerusalem
Italy	Novo Nordisk Investigational Site	Firenze
Italy	Novo Nordisk Investigational Site	Genova
Italy	Novo Nordisk Investigational Site	Pesaro
Italy	Novo Nordisk Investigational Site	Rome
Italy	Novo Nordisk Investigational Site	Udine
Poland	Novo Nordisk Investigational Site	Gdansk
Poland	Novo Nordisk Investigational Site	Katowice
Poland	Novo Nordisk Investigational Site	Poznan
Poland	Novo Nordisk Investigational Site	Warszawa
Poland	Novo Nordisk Investigational Site	Warszawa
Poland	Novo Nordisk Investigational Site	Wroclaw
Poland	Novo Nordisk Investigational Site	Wroclaw
Singapore	Novo Nordisk Investigational Site	Singapore
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Santander
Spain	Novo Nordisk Investigational Site	Valencia
Sweden	Novo Nordisk Investigational Site	Göteborg
Sweden	Novo Nordisk Investigational Site	Stockholm
Sweden	Novo Nordisk Investigational Site	Uppsala
Switzerland	Novo Nordisk Investigational Site	Basel
Switzerland	Novo Nordisk Investigational Site	Zürich
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Novo Nordisk Investigational Site	Bangkok
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Manchester
United States	Novo Nordisk Investigational Site	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Denmark,  Finland,  France,  Germany,  Israel,  Italy,  Poland,  Singapore,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

References & Publications (1)

Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators.. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on bleeding, defined as change in bleeding score			No
Secondary	Transfusion requirements			No
Secondary	Bleeding evaluation			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk