Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

Phase 1

Completed

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

• Registration Number: NCT01205724
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C	turoctocog alfa pegol	-
A	turoctocog alfa pegol	-
B	turoctocog alfa pegol	-

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs) reported after administration of trial product	up to four weeks after trial product administration

Secondary Outcome Measures

Name	Time	Method
Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample)	from 0 to 168 hours after trial product administration
Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments	up to four weeks after trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Manchester, United Kingdom