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

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2017-003788-36-NL
• Date of registration: 21/02/2018
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A research study looking at how a factor VIII medicine called turoctocog alfa pegol (N8-GP) works in people with haemophilia A
• Scientific title: 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
• Date of first enrolment: 24/04/2018
• Target sample size: 170
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003788-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Dosing once, twice or three times weekly; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Clinical Disclosure (1452)
• Affiliation: Novo Nordisk A/S

• Name: Clinical Disclosure (1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male patients of all ages with the diagnosis of severe congenital haemophilia A (FVIII activity <1%) based on medical records
2. On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of transfer
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Intervention(s)

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 descriptive name: TUROCTOCOG ALFA PEGOL
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2000-

Product Name: N8-GP 3000 IU/vial
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 descriptive name: TUROCTOCOG ALFA PEGOL
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 3000-

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: Week 0 to week 104

Primary end point(s): Number of adverse events reported

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

Secondary Outcome(s)

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

Secondary ID(s)

NN7088-4410

2017-003788-36-LT

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 24/04/2018
Contact: