NCT01949792

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

September 13, 2013

Last Update Submit

November 13, 2014

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia A With InhibitorsHaemophilia BHaemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')

    10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg

Secondary Outcomes (1)

  • TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)

    Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg

Study Arms (2)

270 microg/kg rFVIIa

ACTIVE COMPARATOR

Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours

Drug: eptacog alfa (activated)

3x90 microg/kg rFVIIa

ACTIVE COMPARATOR

Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours

Drug: eptacog alfa (activated)

Interventions

eptacog alfa (activated)DRUG

Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)

270 microg/kg rFVIIa

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records

You may not qualify if:

  • Congenital or acquired coagulation disorder other than congenital haemophilia A or B
  • Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)
  • Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)
  • Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Madrid, 28046, Spain

Location

Related Links

MeSH Terms

Conditions

Hemophilia AHemophilia B

Interventions

Factor VII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2013

First Posted

September 25, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

ES(1)