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

Phase 1CompletedNCT01205724

Novo Nordisk A/S27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A

Interventions

turoctocog alfa pegolDRUG

Single dose (low) administered intravenously (into the vein)

turoctocog alfa pegolDRUG

Single dose (medium) administered intravenously (into the vein)

turoctocog alfa pegolDRUG

Single dose (high) administered intravenously (into the vein)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (18)

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Frequency of adverse events (AEs) reported after administration of trial product

Time frame: up to four weeks after trial product administration

Secondary Outcomes

Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample)

Time frame: from 0 to 168 hours after trial product administration

Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments

Time frame: up to four weeks after trial product administration

Data from ClinicalTrials.gov

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