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

Phase 2

Terminated

• Conditions: Bleeding During/Following Surgery; Acquired Bleeding Disorder
• Interventions: Drug: standard therapy; Drug: activated recombinant human factor VII; Drug: placebo

• Registration Number: NCT01564563
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-28
• Primary Completion: 2003-10-27
• Study Completion: 2003-10-27
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	standard therapy	-
High dose	standard therapy	-
Low dose	activated recombinant human factor VII	-
Placebo	placebo	-
High dose	activated recombinant human factor VII	-
Low dose	standard therapy	-

Primary Outcome Measures

Name	Time	Method
Effect on bleeding, defined as change in bleeding score

Secondary Outcome Measures

Name	Time	Method
Changes in safety coagulation parameters
Transfusion requirements
Bleeding evaluation
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Houston, Texas, United States