Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Cirrhosis; Acquired Bleeding Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562821

F7LIVER-1313

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.

Enrollment: 235 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cirrhosis (Child-Turcotte Score A, B, or C)
• Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours

Exclusion criteria

• Portal vein thrombosis
• Clinically documented DVT (deep venous thrombosis)
• Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke
• Present renal insufficiency requiring dialysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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235 participants in 3 patient groups, including a placebo group

Low dose

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

High dose

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Placebo

Placebo Comparator group

Treatment:

Drug: placebo