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

February 23, 2017 updated by: Novo Nordisk A/S

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novo Nordisk Investigational Site
    • California
      • Duarte, California, United States, 91010
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Novo Nordisk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7035
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030-4009
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Placebo
Drug: standard therapy
Standard treatment of bleeding
Experimental: Low dose
Drug: 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)
Drug: activated recombinant human factor VII
Two days repeated treatment regimen - high dose administered i.v. (into the vein)
Experimental: High dose
Drug: 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)
Drug: activated recombinant human factor VII
Two days repeated treatment regimen - high dose administered i.v. (into the vein)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effect on bleeding, defined as change in bleeding score

Secondary Outcome Measures

Outcome Measure
Adverse events
Transfusion requirements
Bleeding evaluation
Changes in safety coagulation parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2002

Primary Completion (Actual)

October 27, 2003

Study Completion (Actual)

October 27, 2003

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7SCT-1485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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