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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01562158

First received: March 22, 2012

Last updated: January 10, 2017

Last verified: January 2017

History of Changes

Purpose

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.

Condition	Intervention	Phase
Acquired Bleeding Disorder Bleeding During/Following Surgery	Procedure: standard therapy Drug: activated recombinant human factor VII Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Bleeding

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

Effect on bleeding, defined as change in bleeding score

Secondary Outcome Measures:

Transfusion requirements
Bleeding evaluation
Adverse events


Enrollment:	100
Study Start Date:	April 2001
Study Completion Date:	October 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Procedure: standard therapy Standard treatment of bleeding Drug: placebo Placebo
Experimental: Low dose	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)
Experimental: Medium dose	Procedure: standard therapy Standard treatment of bleeding Drug: activated recombinant human factor VII Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
Experimental: High dose	Procedure: standard therapy Standard treatment of bleeding Drug: activated recombinant human factor VII Two days repeated treatment regimen - high dose administered i.v. (into the vein)

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562158

Show 46 Study Locations

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Publications:

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. J Thromb Haemost. 2005 Sep;3(9):1935-44.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01562158 History of Changes
Other Study ID Numbers:	F7BMT-1360
Study First Received:	March 22, 2012
Last Updated:	January 10, 2017

Additional relevant MeSH terms:


Hemorrhage Blood Coagulation Disorders Hemostatic Disorders Pathologic Processes	Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders

ClinicalTrials.gov processed this record on June 23, 2017

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