A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: turoctocog alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238367

NN7008-3600

U1111-1117-1286 (Other Identifier)

JapicCTI-101346 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.

Enrollment: 6 patients

Sex: Male

Ages: 12 to 66 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese subjects who have completed NN7008-3543
• No detectable inhibitors to factor VIII

Exclusion criteria

• Congenital or acquired coagulation disorders other than haemophilia A
• Planned surgery during the trial period
• Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

recombinant factor VIII (N8)

Experimental group

Treatment:

Drug: turoctocog alfa