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

Congenital Bleeding Disorder Clinical Trial

Official title:

An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922792
• Other study ID #: NN7128-3700
• Secondary ID: 2009-010080-16
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2009
• Last updated: May 12, 2016
• Start date: June 2009
• Est. completion date: September 2009

Study information

• Verified date: May 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• activated recombinant human factor VII, long acting
Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
• activated recombinant human factor VII, long acting
Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events		after 1 and 2 weeks after dosing	Yes
Primary	Frequency of serious adverse events		after 1, 2 and 6-10 weeks after dosing	Yes
Primary	Frequency of MESIs (Medical Event of Special Interest)		after 1, 2 and 6-10 weeks after dosing	Yes
Primary	Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa		after 2 and 6-10 weeks after dosing	Yes
Secondary	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	No

External Links

•   Clinical Trials at Novo Nordisk