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Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
activated recombinant human factor VII
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

16 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
  • Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product

Exclusion Criteria:

  • Known or suspected allergy to trial product or any of its components or to related products
  • Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
  • Platelet count below 50,000 platelets/mcL
  • Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dose

Medium dose

High dose

Arm Description

Outcomes

Primary Outcome Measures

TEG® (Thromboelastography) parameters after dosing of trial product
ROTEM® (Thromboelastometry) parameters after dosing of trial product

Secondary Outcome Measures

TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
Serious adverse events and non-serious adverse events

Full Information

First Posted
March 21, 2012
Last Updated
May 11, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01562457
Brief Title
Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State
Official Title
A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (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 Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state. The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).

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
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Title
Medium dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
Primary Outcome Measure Information:
Title
TEG® (Thromboelastography) parameters after dosing of trial product
Title
ROTEM® (Thromboelastometry) parameters after dosing of trial product
Secondary Outcome Measure Information:
Title
TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
Title
ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
Title
Serious adverse events and non-serious adverse events

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units) Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product Exclusion Criteria: Known or suspected allergy to trial product or any of its components or to related products Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B Platelet count below 50,000 platelets/mcL Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII
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
Lille
ZIP/Postal Code
59037
Country
France
City
München
ZIP/Postal Code
80336
Country
Germany
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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

Learn more about this trial

Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State

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