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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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
activated recombinant human factor VII, long acting
activated recombinant human factor VII, long acting
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Frequency of adverse events
Frequency of serious adverse events
Frequency of MESIs (Medical Event of Special Interest)
Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2009
Last Updated
May 12, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00922792
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII, long acting
Intervention Description
Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII, long acting
Intervention Description
Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours
Primary Outcome Measure Information:
Title
Frequency of adverse events
Time Frame
after 1 and 2 weeks after dosing
Title
Frequency of serious adverse events
Time Frame
after 1, 2 and 6-10 weeks after dosing
Title
Frequency of MESIs (Medical Event of Special Interest)
Time Frame
after 1, 2 and 6-10 weeks after dosing
Title
Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa
Time Frame
after 2 and 6-10 weeks after dosing
Secondary Outcome Measure Information:
Title
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
Time Frame
from time of dosing up to 72 hours after the last dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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