Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (guardian TM 7)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: turoctocog alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02938585

CTR20160811 (Other Identifier)

NN7008-4028

2013-004791-35 (Registry Identifier)

U1111-1150-0765 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).

Enrollment: 68 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients
• Age from 0 years
• With the diagnosis of severe congenital haemophilia A (FVIII≤1%)
• History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients:
• Patients of 12 years or above: 100 exposures days (ED) or more
• Patients below 12 years: 50 exposure days (ED) or more

Exclusion criteria

• Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory
• Known history of FVIII inhibitors

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Prophylactic treatment

Experimental group

Treatment:

Drug: turoctocog alfa

Drug: turoctocog alfa

On-demand treatment

Experimental group

Treatment:

Drug: turoctocog alfa

Drug: turoctocog alfa