Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia B; Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII, long acting

Study type: Interventional

Funder types: Industry

Identifiers

NCT00922792

2009-010080-16 (EudraCT Number)

NN7128-3700

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Haemophilia A or B
• Bodyweight max 100 kg
• Body Mass Index (BMI) max 30 kg/m2
• Adequate venous access

Exclusion criteria

• Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
• The receipt of any investigational product within 30 days prior to enrolment in this trial
• Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
• The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
• Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
• Known pseudo tumours
• Congenital or acquired coagulation disorders other than haemophilia A or B
• Any major and/or orthopaedic surgery within one month prior to trial start
• Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
• Clinical signs of renal dysfunction
• Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
• Use of non-prescribed opiate substances

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: activated recombinant human factor VII, long acting

Drug: activated recombinant human factor VII, long acting

B

Experimental group

Treatment:

Drug: activated recombinant human factor VII, long acting

Drug: activated recombinant human factor VII, long acting