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

Phase 2

Completed

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

• Registration Number: NCT01562158
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Bleeding evaluation
Transfusion requirements
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Manchester, United Kingdom