A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A
• Interventions: Drug: turoctocog alfa

• Registration Number: NCT01365520
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-30
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

Inclusion Criteria

• Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
• Body weight between 10 to 120 kg
• Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)

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Exclusion Criteria

• Known or suspected hypersensitivity to trial product(s) or related products
• Previous participation in this trial defined as withdrawal
• Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
• Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N8	turoctocog alfa	-

Primary Outcome Measures

Name	Time	Method
Area under the curve	Infusion, 48 hours
In vivo t1/2	Infusion, 48 hours
Total clearance (CL)	Infusion, 48 hours
Incremental recovery	Infusion, 30 minutes

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	up to 48 hours after trial drug administration
Maximal concentration (Cmax)	15 minutes after trial drug administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 London, United Kingdom