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

May 12, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Drug: 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
Experimental: B
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
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
from time of dosing up to 72 hours after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7128-3700
  • 2009-010080-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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