An Open Non-randomised Dose Escalation Trial Investigating the Safety and Pharmacokinetics of Single Intravenous Administrations of NNC128-0000-2011 in Patients With Haemophilia A or B

NCT01288391 Phase 1 COMPLETED

This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	15
Start date	2011-01
Completion	2011-07

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B

Interventions

• NNC 0128-0000-2011
• NNC 0128-0000-2011

Primary outcomes

• Frequency of Adverse Events (AEs) — from first trial product administration until 12 weeks after last trial product administration
• Frequency of serious adverse events (SAEs) — from first trial product administration until 12 weeks after last trial product administration
• Frequency of MESIs (Medical Event of Special Interest) — from first trial product administration until 12 weeks after last trial product administration

Countries

Germany, Japan, Spain