Back to resultsEfficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
Primary Purpose
Acquired Bleeding Disorder, Bleeding During/Following Surgery
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
standard therapy
placebo
activated recombinant human factor VII
activated recombinant human factor VII
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Bleeding Disorder
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Low dose
High dose
Arm Description
Outcomes
Primary Outcome Measures
Effect on bleeding, defined as change in bleeding score
Secondary Outcome Measures
Transfusion requirements
Bleeding evaluation
Adverse events
Changes in safety coagulation parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01564563
Brief Title
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Trial enrollment was prematurely terminated due to excessively slow patient recruitment
Study Start Date
June 28, 2002 (Actual)
Primary Completion Date
October 27, 2003 (Actual)
Study Completion Date
October 27, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Bleeding During/Following Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Low dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
standard therapy
Intervention Description
Standard treatment of bleeding
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
Two days repeated treatment regimen - low dose administered i.v. (into the vein)
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
Two days repeated treatment regimen - high dose administered i.v. (into the vein)
Primary Outcome Measure Information:
Title
Effect on bleeding, defined as change in bleeding score
Secondary Outcome Measure Information:
Title
Transfusion requirements
Title
Bleeding evaluation
Title
Adverse events
Title
Changes in safety coagulation parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7035
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
We'll reach out to this number within 24 hrs