Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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.
Scientific title
Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
Secondary ID [1] 0 0
U1111-1119-7326
Secondary ID [2] 0 0
NN7088-3860
Universal Trial Number (UTN)
Trial acronym
pathfinder™3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Bleeding Disorder 0 0
Haemophilia A 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
Assessed by the Investigator/surgeon at the day of surgery
Secondary outcome [1] 0 0
Average Consumption of N8-GP During Surgery
Timepoint [1] 0 0
During surgery, defined as the time from "knife to skin" until "last stitch"
Secondary outcome [2] 0 0
Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6
Timepoint [2] 0 0
During the post-operative period, days 1-6
Secondary outcome [3] 0 0
Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14
Timepoint [3] 0 0
During the post-operative period, days 7-14
Secondary outcome [4] 0 0
Average Consumption of N8-GP During the Post-operative Period Days 1-6
Timepoint [4] 0 0
During the post-operative period, days 1-6
Secondary outcome [5] 0 0
Incidence Rate of Inhibitors Against Factor VIII (FVIII) (=0.6 BU/mL)
Timepoint [5] 0 0
during the trial (2-5 weeks)
Secondary outcome [6] 0 0
Estimated Blood Loss During Surgery
Timepoint [6] 0 0
During surgery
Secondary outcome [7] 0 0
Number of Transfusions During the Post-operative Period Days 1-6
Timepoint [7] 0 0
Post-operative period, days 1-6
Secondary outcome [8] 0 0
Length of Stay in the Hospital
Timepoint [8] 0 0
During the trial (2-5 weeks)
Secondary outcome [9] 0 0
Number of Days in Intensive Care
Timepoint [9] 0 0
During the trial (2-5 weeks)
Secondary outcome [10] 0 0
Adverse Events Reported During the Trial Period
Timepoint [10] 0 0
During the trial (2-5 weeks)
Secondary outcome [11] 0 0
Serious Adverse Events Reported During the Trial Period
Timepoint [11] 0 0
During the trial (2-5 weeks)

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
Minimum age
12 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/12/2018
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - South Brisbane
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Brazil
State/province [17] 0 0
Sao Paulo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Croatia
State/province [19] 0 0
Split
Country [20] 0 0
Croatia
State/province [20] 0 0
Zagreb
Country [21] 0 0
Denmark
State/province [21] 0 0
København Ø
Country [22] 0 0
Denmark
State/province [22] 0 0
Århus N
Country [23] 0 0
France
State/province [23] 0 0
Bron Cedex
Country [24] 0 0
France
State/province [24] 0 0
Le Kremlin Bicetre
Country [25] 0 0
France
State/province [25] 0 0
Nantes Cedex 1
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Bonn
Country [29] 0 0
Germany
State/province [29] 0 0
Frankfurt/M.
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Homburg
Country [32] 0 0
Germany
State/province [32] 0 0
München
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Debrecen
Country [35] 0 0
Israel
State/province [35] 0 0
Tel-Hashomer
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Udine
Country [38] 0 0
Italy
State/province [38] 0 0
Vicenza
Country [39] 0 0
Japan
State/province [39] 0 0
Kashihara-shi, Nara
Country [40] 0 0
Japan
State/province [40] 0 0
Shinjuku-ku, Tokyo
Country [41] 0 0
Japan
State/province [41] 0 0
Suginami-ku, Tokyo
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Malaysia
State/province [43] 0 0
Kuala Lumpur
Country [44] 0 0
Malaysia
State/province [44] 0 0
Selangor Darul Ehsan
Country [45] 0 0
Netherlands
State/province [45] 0 0
Groningen
Country [46] 0 0
Netherlands
State/province [46] 0 0
Rotterdam
Country [47] 0 0
Norway
State/province [47] 0 0
Oslo
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Málaga
Country [50] 0 0
Sweden
State/province [50] 0 0
Malmö
Country [51] 0 0
Switzerland
State/province [51] 0 0
Genève 14
Country [52] 0 0
Switzerland
State/province [52] 0 0
Lausanne
Country [53] 0 0
Switzerland
State/province [53] 0 0
Zürich
Country [54] 0 0
Taiwan
State/province [54] 0 0
Changhua
Country [55] 0 0
Taiwan
State/province [55] 0 0
Taipei
Country [56] 0 0
Turkey
State/province [56] 0 0
Adana
Country [57] 0 0
Turkey
State/province [57] 0 0
Bornova-IZMIR
Country [58] 0 0
Turkey
State/province [58] 0 0
Samsun
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Basingstoke
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cardiff
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Oxford
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01489111
Trial related presentations / publications
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 haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01489111