NCT01562821|CompletedPhase 2

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

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

F7LIVER-1313

Study Type

interventional

Target

235

Locations

3 countries

Sites

Timeline

RegisteredMar 2012

StartedJul 2001

CompletionDec 2002

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

235

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2001

Shorter than P25 for phase_2

Geographic Reach

3 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

July 1, 2001

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed

9.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed

Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

March 22, 2012

Last Update Submit

January 12, 2017

Conditions

Acquired Bleeding Disorder Cirrhosis

Outcome Measures

Primary Outcomes (1)

The RBC transfusion requirements

Secondary Outcomes (3)

Number of transfusion product units
Change in coagulation-related parameters
Adverse events

Study Arms (3)

Low dose

EXPERIMENTAL

Drug: activated recombinant human factor VII

High dose

EXPERIMENTAL

Drug: activated recombinant human factor VII

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

activated recombinant human factor VIIDRUG

An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery

Low dose

placeboDRUG

An initial placebo bolus dose followed by placebo every second hour until completion of surgery

Placebo

Eligibility Criteria

Age21 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.