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Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02239146
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

Condition or disease Intervention/treatment Phase
Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass Drug: catridecacog Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
Study Start Date : October 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: rFXIII Drug: catridecacog
Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

Placebo Comparator: Placebo Drug: placebo
Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).




Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration ]

Secondary Outcome Measures :
  1. Incidence and magnitude of laboratory abnormalities following administration of rFXIII [ Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration ]
  2. Incidence of antibodies to FXIII-A subunit [ Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration ]
  3. Incidence of anti-yeast antibodies [ Time Frame: From dosing up to 5-7 weeks ± 3 days after trial product administration ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is undergoing his/her first myocardial revascularization

Exclusion Criteria:

  • Previous participation (randomisation and dosing) in this trial
  • Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
  • Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
  • Subject has a current atrial fibrillation or history of atrial fibrillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239146


Locations
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United States, Arizona
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85714
United States, California
Novo Nordisk Investigational Site
San Francisco, California, United States, 94143
United States, Colorado
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80262
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46290
United States, New Jersey
Novo Nordisk Investigational Site
Camden, New Jersey, United States, 08103
United States, New York
Novo Nordisk Investigational Site
Bronx, New York, United States, 10461
Novo Nordisk Investigational Site
Bronx, New York, United States, 10467
Novo Nordisk Investigational Site
New York, New York, United States, 10032
United States, Ohio
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97207
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Novo Nordisk Investigational Site
Allentown, Pennsylvania, United States, 18103
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107-5092
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23298
Canada
Novo Nordisk Investigational Site
Toronto, Canada, M5G-2C4
Denmark
Novo Nordisk Investigational Site
København ø, Denmark, 2100
Germany
Novo Nordisk Investigational Site
Hamburg, Germany, 20246
Novo Nordisk Investigational Site
Lahr, Germany, 77933
Novo Nordisk Investigational Site
Mainz, Germany, 55131
United Kingdom
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB3 8RE
Novo Nordisk Investigational Site
London, United Kingdom, W1G 8PH
Novo Nordisk Investigational Site
Middlesborough, United Kingdom, TS4 3BW
Novo Nordisk Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02239146    
Other Study ID Numbers: F13CARD-1660
2005-000729-40 ( EudraCT Number )
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders