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Clinical Trials/NCT01205724
NCT01205724
Completed
Phase 1

A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A

Novo Nordisk A/S1 site in 1 country27 target enrollmentSeptember 2010
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ConditionsCongenital Bleeding DisorderHaemophilia A
Interventionsturoctocog alfa pegol
Drugsturoctocog alfa pegol

Overview

Phase
Phase 1
Intervention
turoctocog alfa pegol
Conditions
Congenital Bleeding Disorder
Sponsor
Novo Nordisk A/S
Enrollment
27
Locations
1
Primary Endpoint
Frequency of adverse events (AEs) reported after administration of trial product
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
April 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: turoctocog alfa pegol

B

Intervention: turoctocog alfa pegol

C

Intervention: turoctocog alfa pegol

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)(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)

Study Sites (1)

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