Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A (pathfinder™1)

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: turoctocog alfa pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01205724

NN7088-3776

U1111-1116-2043 (Other Identifier)

JapicCTI-101293 (Other Identifier)

2010-018520-68 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Haemophilia A
• Body Mass Index (BMI) below 35 kg/m2
• History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)

Exclusion criteria

• Any history of FVIII inhibitors
• Surgery planned to occur during the trial
• Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
• Congenital or acquired coagulation disorders other than haemophilia A

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: turoctocog alfa pegol

Drug: turoctocog alfa pegol

Drug: turoctocog alfa pegol

B

Experimental group

Treatment:

Drug: turoctocog alfa pegol

Drug: turoctocog alfa pegol

Drug: turoctocog alfa pegol

C

Experimental group

Treatment:

Drug: turoctocog alfa pegol

Drug: turoctocog alfa pegol

Drug: turoctocog alfa pegol