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A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A (pathfinder8)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528551
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE April 30, 2018
Estimated Primary Completion Date December 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Number of adverse events reported [ Time Frame: Weeks 0-104 ]
Count of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Incidence of FVIII inhibitors ≥0.6 BU [ Time Frame: Weeks 0-104 ]
    Count of presence of inhibitors
  • Number of bleeding episodes on prophylaxis [ Time Frame: Weeks 0-104 ]
    Count of episodes
  • Number of spontaneous bleeding episodes on prophylaxis [ Time Frame: Weeks 0-104 ]
    Count of episodes
  • Haemostatic effect of N8-GP when used for treatment of bleeding episodes assessed as: Excellent, Good, Moderate, or None [ Time Frame: Weeks 0-104 ]
    Assessed as: Excellent, good, moderate, or none
  • Number of N8-GP injections required per bleeding episode [ Time Frame: Weeks 0-104 ]
    Number of injections
  • Pre-dose FVIII activity levels on N8-GP prophylaxis (IU/dL) [ Time Frame: Weeks 0-104 ]
    Calculated based on plasma FVIII activity measured in blood
  • Change in joint health status from start to end of trial (based on Haemophilia Joint Health Score) [ Time Frame: Week 0, Week 104 ]
    Based on Haemophilia Joint Health Score
  • Haemostatic response during major surgical interventions assessed as: Excellent, Good, Moderate, or None [ Time Frame: Weeks 0-104 ]
    Assessed as: Excellent, good, moderate, or none
  • Consumption of N8-GP per bleed [ Time Frame: Weeks 0-104 ]
    Number of infusions and IU/kg per bleed
  • Consumption of N8-GP during prophylaxis treatment [ Time Frame: Weeks 0-104 ]
    Number of infusions and IU/kg per month and per year
  • Change from start till end of trial in treatment satisfaction (based on Hemo-SAT score) [ Time Frame: Week 0, Week 104 ]
    Based on Haemophilia Satisfaction Survey (Hemo-SAT) score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
Official Title  ICMJE Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A
Brief Summary This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congenital Bleeding Disorder
  • Haemophilia A
Intervention  ICMJE
  • Drug: Turoctocog alfa pegol
    Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years.
  • Drug: Turoctocog alfa pegol
    Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years.
  • Drug: Turoctocog alfa pegol
    Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.
Study Arms  ICMJE
  • Experimental: N8-GP, once weekly
    All participants will receive turoctocog alfa pegol (N8-GP) once weekly.
    Intervention: Drug: Turoctocog alfa pegol
  • Experimental: N8-GP, twice weekly
    All participants will receive N8-GP twice weekly.
    Intervention: Drug: Turoctocog alfa pegol
  • Experimental: N8-GP, three times weekly
    All participants will receive N8-GP three times weekly.
    Intervention: Drug: Turoctocog alfa pegol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
173
Estimated Study Completion Date  ICMJE December 3, 2020
Estimated Primary Completion Date December 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male patients of all ages with the diagnosis of severe congenital haemophilia A (coagulation Factor VIII [FVIII] activity less than 1%) based on medical records
  • On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of transfer

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
  • Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved investigational medicinal product
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Croatia,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Malaysia,   Netherlands,   Norway,   Portugal,   Puerto Rico,   Spain,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528551
Other Study ID Numbers  ICMJE NN7088-4410
U1111-1202-2780 ( Other Identifier: World Health Organization (WHO) )
2017-003788-36 ( Registry Identifier: European Medicines Agency (EudraCT) )
JapicCTI-183952 ( Registry Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://www.novonordisk-trials.com/website/content/how-to-access-clinical-trial-datasets.aspx
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure 1452 Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP