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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01480180




Registration number
NCT01480180
Ethics application status
Date submitted
23/11/2011
Date registered
28/11/2011
Date last updated
23/11/2020

Titles & IDs
Public title
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
Scientific title
A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A
Secondary ID [1] 0 0
U1111-1119-7416
Secondary ID [2] 0 0
NN7088-3859
Universal Trial Number (UTN)
Trial acronym
pathfinder™2
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: Prophylaxis -

Experimental: On-demand -


Treatment: Drugs: turoctocog alfa pegol
Administered i.v.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Incidence Rate of FVIII-inhibitors =0.6 BU: After Approximately 19 Months
Timepoint [1] 0 0
After approximately 19 months
Primary outcome [2] 0 0
Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months
Timepoint [2] 0 0
After approximately 19 months
Primary outcome [3] 0 0
The Incidence Rate of FVIII-inhibitors =0.6 BU: After Approximately 25 Months
Timepoint [3] 0 0
After approximately 25 months
Primary outcome [4] 0 0
Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months
Timepoint [4] 0 0
After approximately 25 months
Primary outcome [5] 0 0
Incidence Rate of FVIII-inhibitors =0.6 BU: At Approximately 80 Months
Timepoint [5] 0 0
At approximately 80 months
Primary outcome [6] 0 0
Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 80 Months
Timepoint [6] 0 0
After approximately 80 months
Secondary outcome [1] 0 0
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months
Timepoint [1] 0 0
After approximately 19 months
Secondary outcome [2] 0 0
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months
Timepoint [2] 0 0
After approximately 25 months
Secondary outcome [3] 0 0
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months
Timepoint [3] 0 0
After approximately 80 months
Secondary outcome [4] 0 0
Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 19 Months
Timepoint [4] 0 0
After approximately 19 months
Secondary outcome [5] 0 0
Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 25 Months
Timepoint [5] 0 0
After approximately 25 months
Secondary outcome [6] 0 0
Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 80 Months
Timepoint [6] 0 0
After approximately 80 months
Secondary outcome [7] 0 0
Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 19 Months
Timepoint [7] 0 0
After approximately 19 months
Secondary outcome [8] 0 0
Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 25 Months
Timepoint [8] 0 0
After approximately 25 months
Secondary outcome [9] 0 0
Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 80 Months
Timepoint [9] 0 0
After approximately 80 months
Secondary outcome [10] 0 0
Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 19 Months
Timepoint [10] 0 0
After approximately 19 months
Secondary outcome [11] 0 0
Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 25 Months
Timepoint [11] 0 0
After approximately 25 months
Secondary outcome [12] 0 0
Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 80 Months
Timepoint [12] 0 0
After approximately 80 months
Secondary outcome [13] 0 0
Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 19 Months
Timepoint [13] 0 0
After approximately 19 months
Secondary outcome [14] 0 0
Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 25 Months
Timepoint [14] 0 0
After approximately 25 months
Secondary outcome [15] 0 0
Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 80 Months
Timepoint [15] 0 0
After approximately 80 months
Secondary outcome [16] 0 0
Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 19 Months
Timepoint [16] 0 0
After approximately 19 months
Secondary outcome [17] 0 0
Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 25 Months
Timepoint [17] 0 0
After approximately 25 months
Secondary outcome [18] 0 0
Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 80 Months
Timepoint [18] 0 0
After approximately 80 months
Secondary outcome [19] 0 0
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 19 Months
Timepoint [19] 0 0
After approximately 19 months
Secondary outcome [20] 0 0
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 25 Months
Timepoint [20] 0 0
After approximately 25 months
Secondary outcome [21] 0 0
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 80 Months
Timepoint [21] 0 0
After approximately 80 months
Secondary outcome [22] 0 0
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old) After Approx 19 and 25 Months
Timepoint [22] 0 0
After approx 19 and 25 months
Secondary outcome [23] 0 0
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months
Timepoint [23] 0 0
2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Secondary outcome [24] 0 0
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 19 and 25 Months
Timepoint [24] 0 0
After approx 19 and 25 months
Secondary outcome [25] 0 0
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months
Timepoint [25] 0 0
2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Secondary outcome [26] 0 0
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approx 19 and 25 Months
Timepoint [26] 0 0
After approx 19 and 25 months
Secondary outcome [27] 0 0
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months
Timepoint [27] 0 0
2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Secondary outcome [28] 0 0
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months
Timepoint [28] 0 0
After approx 19 and 25 months
Secondary outcome [29] 0 0
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months
Timepoint [29] 0 0
1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Secondary outcome [30] 0 0
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months
Timepoint [30] 0 0
After approx 19 and 25 months
Secondary outcome [31] 0 0
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months
Timepoint [31] 0 0
2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Secondary outcome [32] 0 0
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approx 19 and 25 Months
Timepoint [32] 0 0
After approx 19 and 25 months
Secondary outcome [33] 0 0
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months
Timepoint [33] 0 0
1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Secondary outcome [34] 0 0
Patient Reported Outcomes - Change in European Quality of Life Utility Index: After Approx 19 and 25 Months
Timepoint [34] 0 0
After approx 19 and 25 months
Secondary outcome [35] 0 0
Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months
Timepoint [35] 0 0
1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs
Secondary outcome [36] 0 0
Number of Hospital Admissions During the Trial
Timepoint [36] 0 0
After approx 19, 25 and 80 months
Secondary outcome [37] 0 0
Number of Days at the Hospital During the Trial
Timepoint [37] 0 0
After approx 19, 25 and 80 months
Secondary outcome [38] 0 0
Number of Admissions to the Emergency Room (ER) During the Trial
Timepoint [38] 0 0
After approx 19, 25 and 80 months
Secondary outcome [39] 0 0
Number of Days Missing School or Work
Timepoint [39] 0 0
Approx 19, 25 and 80 months
Secondary outcome [40] 0 0
Number of Days Using Mobility Aid
Timepoint [40] 0 0
Approx 19, 25 and 80 months
Secondary outcome [41] 0 0
Number of Participants Using Pain Medication
Timepoint [41] 0 0
After approx 25 and 80 months
Secondary outcome [42] 0 0
Number of Bleeds Using Pain Medication
Timepoint [42] 0 0
After approx 19 months
Secondary outcome [43] 0 0
Number of Adverse Events Reported During the Trial Period: After Approximately 19 Months
Timepoint [43] 0 0
After approx 19 months
Secondary outcome [44] 0 0
Number of Adverse Events Reported During the Trial Period: After Approximately 25 Months
Timepoint [44] 0 0
After approx. 25 months
Secondary outcome [45] 0 0
Number of Adverse Events Reported During the Trial Period: After Approximately 80 Months
Timepoint [45] 0 0
After approximately 80 months
Secondary outcome [46] 0 0
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 19 Months
Timepoint [46] 0 0
After approximately 19 months
Secondary outcome [47] 0 0
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 25 Months
Timepoint [47] 0 0
After approximately 25 months
Secondary outcome [48] 0 0
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 80 Months
Timepoint [48] 0 0
After approximately 80 months
Secondary outcome [49] 0 0
Change in Blood Pressure: After Approximately 19 Months
Timepoint [49] 0 0
After approximately 19 months
Secondary outcome [50] 0 0
Change in Blood Pressure: After Approximately 25 Months
Timepoint [50] 0 0
After approximately 19 and 25 months
Secondary outcome [51] 0 0
Change in Blood Pressure: After Approximately 80 Months
Timepoint [51] 0 0
After approximately 80 months
Secondary outcome [52] 0 0
Change in Pulse: After Approximately 19 Months
Timepoint [52] 0 0
After approximately 19 months
Secondary outcome [53] 0 0
Change in Pulse: After Approximately 25 Months
Timepoint [53] 0 0
After approximately 25 months
Secondary outcome [54] 0 0
Change in Pulse: After Approximately 80 Months
Timepoint [54] 0 0
After approximately 80 months
Secondary outcome [55] 0 0
Change in Body Temperature: After Approximately 19 Months
Timepoint [55] 0 0
After approximately 19 months
Secondary outcome [56] 0 0
Change in Body Temperature: After Approximately 25 Months
Timepoint [56] 0 0
After approximately 25 months
Secondary outcome [57] 0 0
Change in Body Temperature: After Approximately 80 Months
Timepoint [57] 0 0
After approximately 80 months
Secondary outcome [58] 0 0
Change in Respiratory Rate: After Approximately 19 Months
Timepoint [58] 0 0
After approximately 19 months
Secondary outcome [59] 0 0
Change in Respiratory Rate: After Approximately 25 Months
Timepoint [59] 0 0
After approximately 25 months
Secondary outcome [60] 0 0
Change in Respiratory Rate: After Approximately 80 Months
Timepoint [60] 0 0
After approximately 80 months
Secondary outcome [61] 0 0
FVIII Activity 30 Min Post -Injection (C30min)
Timepoint [61] 0 0
Week 0, week 28
Secondary outcome [62] 0 0
Incremental Recovery (Single Dose and Steady State)
Timepoint [62] 0 0
Week 0, week 28
Secondary outcome [63] 0 0
Trough Level (Single Dose and Steady State)
Timepoint [63] 0 0
Week 0, week 28
Secondary outcome [64] 0 0
Area Under the Curve (AUC0-inf)
Timepoint [64] 0 0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Secondary outcome [65] 0 0
Area Under the Curve (AUC0-t)
Timepoint [65] 0 0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Secondary outcome [66] 0 0
Terminal Half Life (t1/2)
Timepoint [66] 0 0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Secondary outcome [67] 0 0
Clearance (CL)
Timepoint [67] 0 0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Secondary outcome [68] 0 0
Mean Residence Time (MRT)
Timepoint [68] 0 0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28
Secondary outcome [69] 0 0
Volume of Distribution at Steady State (Vss)
Timepoint [69] 0 0
Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28

Eligibility
Key inclusion criteria
- Male patients with severe congenital haemophilia A (FVIII activity below 1%, according to medical records) - Documented history of at least 150 EDs (exposure days) to other FVIII products - At least 12 years and body weight at least 35 kg (except for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be 18 years)
Minimum age
12 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous participation in this trial defined as withdrawal after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral load of more than 400000 copies/mL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired coagulation disorders other than haemophilia A - Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory - Creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges) - Ongoing immune modulating or chemotherapeutic medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
30/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/12/2018
Sample size
Target
Accrual to date
Final
186
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
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sofia
Country [25] 0 0
Croatia
State/province [25] 0 0
Split
Country [26] 0 0
Croatia
State/province [26] 0 0
Zagreb
Country [27] 0 0
Denmark
State/province [27] 0 0
København Ø
Country [28] 0 0
Denmark
State/province [28] 0 0
Århus N
Country [29] 0 0
France
State/province [29] 0 0
Bron Cedex
Country [30] 0 0
France
State/province [30] 0 0
Kremlin-Bicêtre
Country [31] 0 0
France
State/province [31] 0 0
Nantes Cedex 1
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Bonn
Country [35] 0 0
Germany
State/province [35] 0 0
Frankfurt/M.
Country [36] 0 0
Germany
State/province [36] 0 0
Hannover
Country [37] 0 0
Germany
State/province [37] 0 0
Homburg
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Debrecen
Country [41] 0 0
Israel
State/province [41] 0 0
Tel-Hashomer
Country [42] 0 0
Italy
State/province [42] 0 0
Firenze
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Udine
Country [45] 0 0
Italy
State/province [45] 0 0
Vicenza
Country [46] 0 0
Japan
State/province [46] 0 0
Aichi
Country [47] 0 0
Japan
State/province [47] 0 0
Hiroshima
Country [48] 0 0
Japan
State/province [48] 0 0
Kitakyusyu, Fukuoka
Country [49] 0 0
Japan
State/province [49] 0 0
Nara
Country [50] 0 0
Japan
State/province [50] 0 0
Saitama
Country [51] 0 0
Japan
State/province [51] 0 0
Shimotsuke-shi, Tochigi
Country [52] 0 0
Japan
State/province [52] 0 0
Shizuoka
Country [53] 0 0
Japan
State/province [53] 0 0
Tokyo
Country [54] 0 0
Japan
State/province [54] 0 0
Yokohama-shi, Kanagawa
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Daejeon
Country [56] 0 0
Malaysia
State/province [56] 0 0
Kuala Lumpur
Country [57] 0 0
Malaysia
State/province [57] 0 0
Selangor Darul Ehsan
Country [58] 0 0
Netherlands
State/province [58] 0 0
Groningen
Country [59] 0 0
Netherlands
State/province [59] 0 0
Rotterdam
Country [60] 0 0
Norway
State/province [60] 0 0
Oslo
Country [61] 0 0
Puerto Rico
State/province [61] 0 0
San Juan
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saint-Petersburg
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Málaga
Country [65] 0 0
Sweden
State/province [65] 0 0
Malmö
Country [66] 0 0
Switzerland
State/province [66] 0 0
Genève 14
Country [67] 0 0
Switzerland
State/province [67] 0 0
Lausanne
Country [68] 0 0
Switzerland
State/province [68] 0 0
Zürich
Country [69] 0 0
Taiwan
State/province [69] 0 0
Changhua
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei
Country [71] 0 0
Turkey
State/province [71] 0 0
Adana
Country [72] 0 0
Turkey
State/province [72] 0 0
Bornova-IZMIR
Country [73] 0 0
Turkey
State/province [73] 0 0
Samsun
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Basingstoke
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Cardiff
Country [76] 0 0
United Kingdom
State/province [76] 0 0
London
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Oxford
Country [78] 0 0
United Kingdom
State/province [78] 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 the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.
Trial website
https://clinicaltrials.gov/study/NCT01480180
Trial related presentations / publications
Giangrande P, Chowdary P, Enhrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WHO, Oldenburg J and on behalf of for the pathfinder™2 Investigators. Clinical evaluation of novel recombinant glycopegylated FVIII (turoctocog alfa pegol, N8-GP): efficacy and safety in previously treated patients with severe hemophilia A - results of pathfinder™2 international trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR212]
Giangrande P, Andreeva T, Chowdary P, Ehrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WH, Jonsson PG, Oldenburg J; Pathfinder2 Investigators. Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A. Thromb Haemost. 2017 Jan 26;117(2):252-261. doi: 10.1160/TH16-06-0444. Epub 2016 Dec 1. Erratum In: Thromb Haemost. 2017 Jun;117(6):1163. doi: 10.1055/s-0039-1692336.
Giangrande P, Abdul Karim F, Nemes L, You CW, Landorph A, Geybels MS, Curry N. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2. J Thromb Haemost. 2020 Sep;18 Suppl 1(Suppl 1):5-14. doi: 10.1111/jth.14959.
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/NCT01480180