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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01489111
Other study ID # NN7088-3860
Secondary ID U1111-1119-73262
Status Completed
Phase Phase 3
First received
Last updated
Start date August 3, 2012
Est. completion date December 10, 2018

Study information

Verified date July 2020
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 10, 2018
Est. primary completion date December 10, 2018
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

- Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP

- Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days

- The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures

Exclusion Criteria:

- Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products

- Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)

- The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)

- FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening

- Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)

- Immune modulating or chemotherapeutic medication

- Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome

- Unwillingness, language or other barriers precluding adequate understanding and/or cooperation

Study Design


Intervention

Drug:
turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.

Locations

Country Name City State
Australia Novo Nordisk Investigational Site Camperdown New South Wales
Australia Novo Nordisk Investigational Site Parkville Victoria
Australia Novo Nordisk Investigational Site South Brisbane Queensland
Brazil Novo Nordisk Investigational Site Campinas Sao Paulo
Bulgaria Novo Nordisk Investigational Site Sofia
Croatia Novo Nordisk Investigational Site Split
Croatia Novo Nordisk Investigational Site Zagreb
Denmark Novo Nordisk Investigational Site Århus N
Denmark Novo Nordisk Investigational Site København Ø
France Novo Nordisk Investigational Site Bron Cedex
France Novo Nordisk Investigational Site Le Kremlin Bicetre
France Novo Nordisk Investigational Site Nantes Cedex 1
France Novo Nordisk Investigational Site Paris
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Bonn
Germany Novo Nordisk Investigational Site Frankfurt/M.
Germany Novo Nordisk Investigational Site Hannover
Germany Novo Nordisk Investigational Site Homburg
Germany Novo Nordisk Investigational Site München
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Debrecen
Israel Novo Nordisk Investigational Site Tel-Hashomer
Italy Novo Nordisk Investigational Site Milano
Italy Novo Nordisk Investigational Site Udine
Italy Novo Nordisk Investigational Site Vicenza
Japan Novo Nordisk Investigational Site Kashihara-shi, Nara
Japan Novo Nordisk Investigational Site Shinjuku-ku, Tokyo
Japan Novo Nordisk Investigational Site Suginami-ku, Tokyo
Japan Novo Nordisk Investigational Site Tokyo
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Malaysia Novo Nordisk Investigational Site Selangor Darul Ehsan
Netherlands Novo Nordisk Investigational Site Groningen
Netherlands Novo Nordisk Investigational Site Rotterdam
Norway Novo Nordisk Investigational Site Oslo
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Sweden Novo Nordisk Investigational Site Malmö
Switzerland Novo Nordisk Investigational Site Genève 14
Switzerland Novo Nordisk Investigational Site Lausanne
Switzerland Novo Nordisk Investigational Site Zürich
Taiwan Novo Nordisk Investigational Site Changhua
Taiwan Novo Nordisk Investigational Site Taipei
Turkey Novo Nordisk Investigational Site Adana
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Turkey Novo Nordisk Investigational Site Samsun
United Kingdom Novo Nordisk Investigational Site Basingstoke
United Kingdom Novo Nordisk Investigational Site Cardiff
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Oxford
United Kingdom Novo Nordisk Investigational Site Sheffield
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Boise Idaho
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Long Beach California
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site New Orleans Louisiana
United States Novo Nordisk Investigational Site Newark New Jersey
United States Novo Nordisk Investigational Site Norfolk Virginia
United States Novo Nordisk Investigational Site Orlando Florida
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Sacramento California
United States Novo Nordisk Investigational Site Spokane Washington
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Croatia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Malaysia,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (1)

Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None Haemostatic effect during surgery was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. This was assessed after completion of surgery (defined as "last stitch").
Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
Assessed by the Investigator/surgeon at the day of surgery
Secondary Average Consumption of N8-GP During Surgery Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'. During surgery, defined as the time from "knife to skin" until "last stitch"
Secondary Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6 Haemostatic effect during post-operative period days 1-6 as evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.
Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
During the post-operative period, days 1-6
Secondary Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14 Haemostatic effect during post-operative period days 1-6 and days 7-14 was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.
Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
During the post-operative period, days 7-14
Secondary Average Consumption of N8-GP During the Post-operative Period Days 1-6 Average consumption of N8-GP during post operative period days 1-6 is presented. Analysis population: Full analysis set included all subjects exposed to the trial drug (N8-GP) and completed surgery. During the post-operative period, days 1-6
Secondary Incidence Rate of Inhibitors Against Factor VIII (FVIII) (=0.6 BU/mL) Incidence rate of inhibitors is the number of newly developed inhibitors per surgery. Development of FVIII inhibitors was measured by a validated Nijmegen modified Bethesda assay. A positive inhibitor test was defined as =0.6 bethesda unit. Number of participants with inhibitors at the end of trial is presented. during the trial (2-5 weeks)
Secondary Estimated Blood Loss During Surgery The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery. During surgery
Secondary Number of Transfusions During the Post-operative Period Days 1-6 Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1-6 is presented. Post-operative period, days 1-6
Secondary Length of Stay in the Hospital Mean number of days stayed at the hospital during the trial. During the trial (2-5 weeks)
Secondary Number of Days in Intensive Care Mean number of days in the intensive care due to surgery during the trial is presented. During the trial (2-5 weeks)
Secondary Adverse Events Reported During the Trial Period Number of adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14). During the trial (2-5 weeks)
Secondary Serious Adverse Events Reported During the Trial Period Number of serious adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14). During the trial (2-5 weeks)
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