A research study looking at how a factor VIII medicine called turoctocog alfa pegol (N8-GP) works in people with haemophilia A

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 - pathfinder8

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003788-36-LT

Enrollment

170

Registered

2018-01-22

Start date

2018-03-12

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A MedDRA version: 20.0 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850

Interventions

Product Name: N8-GP rFVIII Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: turoctocog alfa pegol CAS Number: *MASKED* Current Sponsor code: NNC129-1003 Other de

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male patients of all ages with the diagnosis of severe congenital haemophilia A (FVIII activity =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products 2. Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol 3. Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved investigational medicinal product

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.;Secondary Objective: To investigate the following in severe haemophilia A patients previously treated with turoctocog alfa pegol 1. Development of FVIII inhibitors 2. Efficacy of turoctocog alfa pegol prophylaxis 3. Haemostatic efficacy of turoctocog alfa pegol when used for treatment of bleeds;Primary end point(s): Number of adverse events reported;Timepoint(s) of evaluation of this end point: Week 0 to week 104	—

Measure

Time frame

Main Objective: To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.;Secondary Objective: To investigate the following in severe haemophilia A patients previously treated with turoctocog alfa pegol 1. Development of FVIII inhibitors 2. Efficacy of turoctocog alfa pegol prophylaxis 3. Haemostatic efficacy of turoctocog alfa pegol when used for treatment of bleeds;Primary end point(s): Number of adverse events reported;Timepoint(s) of evaluation of this end point: Week 0 to week 104

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Secondary

Measure	Time frame
Secondary end point(s): 1. Incidence of FVIII inhibitors =0.6 BU 2. Number of bleeding episodes on prophylaxis 3. Number of spontaneous bleeding episodes on prophylaxis 4. Haemostatic effect of turoctocog alfa pegol when used for treatment of bleeding episodes assessed as: Excellent, Good, Moderate, or None 5. Number of turoctocog alfa pegol injections required per bleeding episode;Timepoint(s) of evaluation of this end point: 1. - 5: After 104 weeks	—

Measure

Time frame

Secondary end point(s): 1. Incidence of FVIII inhibitors =0.6 BU 2. Number of bleeding episodes on prophylaxis 3. Number of spontaneous bleeding episodes on prophylaxis 4. Haemostatic effect of turoctocog alfa pegol when used for treatment of bleeding episodes assessed as: Excellent, Good, Moderate, or None 5. Number of turoctocog alfa pegol injections required per bleeding episode;Timepoint(s) of evaluation of this end point: 1. - 5: After 104 weeks

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Countries

Australia, Brazil, Canada, Croatia, Denmark, European Union, France, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Lithuania, Malaysia, Netherlands, Norway, Portugal, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Disclosure (1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026