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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
• Interventions: Drug: activated recombinant human factor VII, long acting

• Registration Number: NCT00922792
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	activated recombinant human factor VII, long acting	-
A	activated recombinant human factor VII, long acting	-

Primary Outcome Measures

Name	Time	Method
Frequency of serious adverse events	after 1, 2 and 6-10 weeks after dosing
Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa	after 2 and 6-10 weeks after dosing
Frequency of adverse events	after 1 and 2 weeks after dosing
Frequency of MESIs (Medical Event of Special Interest)	after 1, 2 and 6-10 weeks after dosing

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½	from time of dosing up to 72 hours after the last dose