NCT00486278|CompletedPhase 2ResultsDMC

Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1731-18042006-004879-35CTI-080612

Study Type

interventional

Target

Locations

18 countries

Sites

Timeline

RegisteredJun 2007

StartedJun 2007

CompletionJun 2010

Brief Summary

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jun 2007

Typical duration for phase_2

Geographic Reach

18 countries

45 active sites

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

3 years study duration

Study Start

First participant enrolled

June 1, 2007

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2007

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed

4.6 years until next milestone

Results Posted

Study results publicly available

December 25, 2014

Completed

Last Updated

March 7, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

June 13, 2007

Results QC Date

September 27, 2013

Last Update Submit

January 23, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B

Outcome Measures

Primary Outcomes (1)

Number of Adverse Events (AEs)
Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.

Secondary Outcomes (20)

Activated Recombinant Human Factor VII Analogue Activity in the Blood
0-24 hours after trial product administration
Prothrombin Time (PT)
pre-dose - 12 hours after trial product administration
F1 + 2 (Prothrombin Fragments 1+2)
pre-dose - 12 hours after trial product administration
Activated Partial Thromboplastin Time (aPTT)
pre-dose - 12 hours after trial product administration
Cessation of Bleeding: Number of Doses Needed to Control Bleeding
Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)
+15 more secondary outcomes

Study Arms (6)

vatreptacog alfa 5 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated)

vatreptacog alfa 10 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated)

vatreptacog alfa 20 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated)

vatreptacog alfa 40 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated)

vatreptacog alfa 80 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated)

rFVIIa 90 mcg/kg

EXPERIMENTAL

Drug: eptacog alfa (activated)

Interventions

eptacog alfa (activated)DRUG

90 mcg/kg, injected i.v.

rFVIIa 90 mcg/kg

vatreptacog alfa (activated)DRUG

5 mcg/kg, injected i.v.

vatreptacog alfa 5 mcg/kg

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

years of age or older (at least 18 years in Croatia, France and United Kingdom (UK))
Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry

You may not qualify if:

Known allergy to rFVIIa, and/or suspected allergy to trial product
Platelet count lower than 50,000 mm\^3 based on medical records at trial entry (visit 1)
Any clinical signs or history of thromboembolic events
Advanced atherosclerotic disease
Severe liver disease based on medical records within the past 12 months at trial entry (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit of normal reference range
Known active pseudo tumours (documented bleeding requiring treatment within the last 3 months
Subject had any (major) surgical procedure in the 30 days prior to screening into the trial. a. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject

Contact the study team to confirm eligibility.