Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

Phase 2

Completed

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

• Registration Number: NCT01563458
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Scheduled to undergo orthotopic liver transplantation
• Liver disease classified as Child-Turcotte (Pughs modification) score B or C

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Exclusion Criteria

• Previous liver transplantation
• Scheduled multi-organ transplantation
• Scheduled for living related donor transplantation
• Present renal insufficiency requiring dialysis
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total number of RBC units transfused during the perioperative period

Secondary Outcome Measures

Name	Time	Method
Number of RBC units transfused by surgical phase
Adverse events
Changes in coagulation related parameters

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 London, United Kingdom