Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.

Congenital Bleeding Disorder Clinical Trial

— pathfinder™3  

Official title:

Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

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
• 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
• 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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Hemophilia A
• Hemostatic Disorders

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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