Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01563458
First received: March 22, 2012
Last updated: December 10, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acquired Bleeding Disorder Bleeding During/Following Surgery |
Drug: activated recombinant human factor VII Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Total number of RBC units transfused during the perioperative period [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 208 |
| Study Start Date: | August 2001 |
| Study Completion Date: | August 2002 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: High dose |
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
|
| Experimental: Low dose |
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
|
| Placebo Comparator: Placebo |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563458
Locations
| Australia | |
| Heidelberg, Australia, 3084 | |
| Canada | |
| London, Canada, N6A 5A5 | |
| Germany | |
| Berlin, Germany, 13353 | |
| Spain | |
| Barcelona, Spain, 8036 | |
| Sweden | |
| Göteborg, Sweden, 413 45 | |
| United Kingdom | |
| Leeds, United Kingdom, LS9 7TF | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Peter B. Schelde | Novo Nordisk |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01563458 History of Changes |
| Other Study ID Numbers: | F7LIVER-1256 |
| Study First Received: | March 22, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Sweden: Medical Products Agency Spain: Spanish Agency for Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemorrhage |
Hematologic Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013