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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: Turoctocog alfa pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03528551

JapicCTI-183952 (Registry Identifier)

NN7088-4410

2017-003788-36 (Registry Identifier)

U1111-1202-2780 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 3 patient groups

N8-GP, once weekly

Experimental group

Description:

All participants will receive turoctocog alfa pegol (N8-GP) once weekly.

Treatment:

Drug: Turoctocog alfa pegol

N8-GP, twice weekly

Experimental group

Description:

All participants will receive N8-GP twice weekly.

Treatment:

Drug: Turoctocog alfa pegol

N8-GP, three times weekly

Experimental group

Description:

All participants will receive N8-GP three times weekly.

Treatment:

Drug: Turoctocog alfa pegol