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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Bleeding During/Following Surgery; Acquired Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563458

F7LIVER-1256

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 3 patient groups, including a placebo group

High dose

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Low dose

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Placebo

Placebo Comparator group

Treatment:

Drug: placebo