Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01489111
Registration number
NCT01489111
Ethics application status
Date submitted
23/11/2011
Date registered
9/12/2011
Date last updated
10/08/2020
Titles & IDs
Public title
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
Query!
Scientific title
Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
Query!
Secondary ID [1]
0
0
U1111-1119-7326
Query!
Secondary ID [2]
0
0
NN7088-3860
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
pathfinder™3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Congenital Bleeding Disorder
0
0
Query!
Haemophilia A
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - turoctocog alfa pegol
Experimental: Surgery -
Treatment: Drugs: turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Assessed by the Investigator/surgeon at the day of surgery
Query!
Secondary outcome [1]
0
0
Average Consumption of N8-GP During Surgery
Query!
Assessment method [1]
0
0
Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'.
Query!
Timepoint [1]
0
0
During surgery, defined as the time from "knife to skin" until "last stitch"
Query!
Secondary outcome [2]
0
0
Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
During the post-operative period, days 1-6
Query!
Secondary outcome [3]
0
0
Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
During the post-operative period, days 7-14
Query!
Secondary outcome [4]
0
0
Average Consumption of N8-GP During the Post-operative Period Days 1-6
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
During the post-operative period, days 1-6
Query!
Secondary outcome [5]
0
0
Incidence Rate of Inhibitors Against Factor VIII (FVIII) (=0.6 BU/mL)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
during the trial (2-5 weeks)
Query!
Secondary outcome [6]
0
0
Estimated Blood Loss During Surgery
Query!
Assessment method [6]
0
0
The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery.
Query!
Timepoint [6]
0
0
During surgery
Query!
Secondary outcome [7]
0
0
Number of Transfusions During the Post-operative Period Days 1-6
Query!
Assessment method [7]
0
0
Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1-6 is presented.
Query!
Timepoint [7]
0
0
Post-operative period, days 1-6
Query!
Secondary outcome [8]
0
0
Length of Stay in the Hospital
Query!
Assessment method [8]
0
0
Mean number of days stayed at the hospital during the trial.
Query!
Timepoint [8]
0
0
During the trial (2-5 weeks)
Query!
Secondary outcome [9]
0
0
Number of Days in Intensive Care
Query!
Assessment method [9]
0
0
Mean number of days in the intensive care due to surgery during the trial is presented.
Query!
Timepoint [9]
0
0
During the trial (2-5 weeks)
Query!
Secondary outcome [10]
0
0
Adverse Events Reported During the Trial Period
Query!
Assessment method [10]
0
0
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).
Query!
Timepoint [10]
0
0
During the trial (2-5 weeks)
Query!
Secondary outcome [11]
0
0
Serious Adverse Events Reported During the Trial Period
Query!
Assessment method [11]
0
0
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).
Query!
Timepoint [11]
0
0
During the trial (2-5 weeks)
Query!
Eligibility
Key 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
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/08/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/12/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
36
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - South Brisbane
Query!
Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Idaho
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Iowa
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Jersey
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oregon
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Virginia
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Washington
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Sao Paulo
Query!
Country [18]
0
0
Bulgaria
Query!
State/province [18]
0
0
Sofia
Query!
Country [19]
0
0
Croatia
Query!
State/province [19]
0
0
Split
Query!
Country [20]
0
0
Croatia
Query!
State/province [20]
0
0
Zagreb
Query!
Country [21]
0
0
Denmark
Query!
State/province [21]
0
0
København Ø
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Århus N
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Bron Cedex
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Le Kremlin Bicetre
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Nantes Cedex 1
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Paris
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Berlin
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Bonn
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Frankfurt/M.
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hannover
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Homburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
München
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Budapest
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Debrecen
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Tel-Hashomer
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Milano
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Udine
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Vicenza
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Kashihara-shi, Nara
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Shinjuku-ku, Tokyo
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Suginami-ku, Tokyo
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Tokyo
Query!
Country [43]
0
0
Malaysia
Query!
State/province [43]
0
0
Kuala Lumpur
Query!
Country [44]
0
0
Malaysia
Query!
State/province [44]
0
0
Selangor Darul Ehsan
Query!
Country [45]
0
0
Netherlands
Query!
State/province [45]
0
0
Groningen
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Rotterdam
Query!
Country [47]
0
0
Norway
Query!
State/province [47]
0
0
Oslo
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Madrid
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Málaga
Query!
Country [50]
0
0
Sweden
Query!
State/province [50]
0
0
Malmö
Query!
Country [51]
0
0
Switzerland
Query!
State/province [51]
0
0
Genève 14
Query!
Country [52]
0
0
Switzerland
Query!
State/province [52]
0
0
Lausanne
Query!
Country [53]
0
0
Switzerland
Query!
State/province [53]
0
0
Zürich
Query!
Country [54]
0
0
Taiwan
Query!
State/province [54]
0
0
Changhua
Query!
Country [55]
0
0
Taiwan
Query!
State/province [55]
0
0
Taipei
Query!
Country [56]
0
0
Turkey
Query!
State/province [56]
0
0
Adana
Query!
Country [57]
0
0
Turkey
Query!
State/province [57]
0
0
Bornova-IZMIR
Query!
Country [58]
0
0
Turkey
Query!
State/province [58]
0
0
Samsun
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
Basingstoke
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Cardiff
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
London
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Oxford
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novo Nordisk A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01489111
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Global Clinical Registry (GCR, 1452)
Query!
Address
0
0
Novo Nordisk A/S
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01489111
Download to PDF