Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01563458
First received: March 22, 2012
Last updated: June 23, 2014
Last verified: June 2014

March 22, 2012
June 23, 2014
August 2001
September 2003   (final data collection date for primary outcome measure)
Total number of RBC units transfused during the perioperative period [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01563458 on ClinicalTrials.gov Archive Site
  • Number of RBC units transfused by surgical phase [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • Changes in coagulation related parameters [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Bleeding During/Following Surgery
  • Drug: activated recombinant human factor VII
    120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
  • Drug: activated recombinant human factor VII
    60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure
  • Drug: placebo
    Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure
  • Experimental: High dose
    Intervention: Drug: activated recombinant human factor VII
  • Experimental: Low dose
    Intervention: Drug: activated recombinant human factor VII
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
September 2003
September 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Germany,   Spain,   Sweden,   United Kingdom
 
NCT01563458
F7LIVER-1256
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP