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

Completed · Phase 1

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

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.

Key facts

Study ID

NCT01205724

Run by

Novo Nordisk A/S

People needed

27

Starts

2010-09-01

Expected to finish

2011-04-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Frankfurt/M., Germany
• Novo Nordisk Investigational Site — Giessen, Germany
• Novo Nordisk Investigational Site — Hanover, Germany
• Novo Nordisk Investigational Site — Florence, Italy
• Novo Nordisk Investigational Site — Vicenza, Italy
• Novo Nordisk Investigational Site — Kashihara-shi, Nara, Japan
• Novo Nordisk Investigational Site — Nagoya-shi, Aichi, Japan
• Novo Nordisk Investigational Site — Shinjuku-ku, Tokyo, Japan
• Novo Nordisk Investigational Site — Zurich, Switzerland
• Novo Nordisk Investigational Site — Bornova-IZMIR, Turkey (Türkiye)
• Novo Nordisk Investigational Site — London, United Kingdom
• Novo Nordisk Investigational Site — London, United Kingdom
• Novo Nordisk Investigational Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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