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NCT01564563 Clinical Trial

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

Acquired Bleeding Disorder Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01564563
Other study ID # F7SCT-1485
Secondary ID
Status Terminated
Phase Phase 2
First received March 23, 2012
Last updated February 23, 2017
Start date June 28, 2002
Est. completion date October 27, 2003

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date October 27, 2003
Est. primary completion date October 27, 2003
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Patients who have undergone a hematopoietic 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

Related Conditions & MeSH terms

Intervention

Drug:
• standard therapy
Standard treatment of bleeding
• placebo
Placebo
• 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 - high dose administered i.v. (into the vein)

Locations
Country Name City State
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Chapel Hill North Carolina
United States Novo Nordisk Investigational Site Duarte California
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Little Rock Arkansas
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect on bleeding, defined as change in bleeding score
Secondary Transfusion requirements
Secondary Bleeding evaluation
Secondary Adverse events
Secondary Changes in safety coagulation parameters
See also
  Status Clinical Trial Phase
Completed NCT01601457 - Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction Phase 2
Completed NCT00124293 - Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury N/A
Terminated NCT00184548 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Phase 3
Completed NCT02239146 - Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass Phase 1
Completed NCT01563445 - Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage Phase 2
Withdrawn NCT00323570 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma Phase 3
Completed NCT00127283 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 3
Completed NCT01563523 - Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients Phase 2
Completed NCT01153997 - Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers Phase 1
Completed NCT00697320 - Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany N/A
Completed NCT00914589 - Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery Phase 2
Completed NCT00102037 - Use of Activated Recombinant FVII in Spinal Surgery Phase 2
Completed NCT01601613 - Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever Phase 2
Completed NCT01562821 - Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy Phase 2
Completed NCT00266006 - Factor VIIa in Acute Intracerebral Haemorrhage Phase 2
Completed NCT00123591 - Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury Phase 2
Completed NCT01562574 - Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease Phase 3
Completed NCT01285089 - Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia N/A
Terminated NCT00154427 - Use of Activated Recombinant Human Factor VII in Cardiac Surgery Phase 2
Completed NCT00426803 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 2

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