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Completed

NCT Number: NCT01205724

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Haemophilia A Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Frankfurt/M., Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Turoctocog alfa pegol

Drug

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

Other names: NNC 0129-0000-1003

Primary outcomes

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

    Time frame: up to four weeks after trial product administration

Secondary outcomes

  1. 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

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

    Time frame: up to four weeks after trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: pathfinder™1

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2010
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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