NCT00951405|CompletedPhase 2DMC

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors

An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of Prophylactic Administration of Long Acting rFVIIa (LA-rFVIIa) in Haemophilia A or B Patients With Inhibitors

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN7128-19072008-006424-54JapicCTI-090860U1111-1111-8584

Study Type

interventional

Target

Locations

9 countries

Sites

Timeline

RegisteredAug 2009

StartedSep 2009

CompletionMar 2011

Brief Summary

This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for 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 below P25 for phase_2

Timeline

Completed

Started Sep 2009

Geographic Reach

9 countries

23 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

1.6 years study duration

First Submitted

Initial submission to the registry

August 3, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed

28 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2011

Completed

Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

August 3, 2009

Last Update Submit

September 3, 2018

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (2)

Thrombogenecity
at all scheduled visits (1 - 9)
Immunogenecity: Neutralising Antibody Development
at all scheduled visits (1 - 9)

Secondary Outcomes (2)

AUC(0-48h) and AUC: Area under the FVIIa activity-time profile in the given time period, which is a measure of total blood exposure
at visit 2 and visit 7 until 48 hours after trial product administration
Annualized bleeding rates
During observation period; from visit 1 until visit 2 and treatment period; from visit 2 until visit 7. In total a period of 6 to 8 months

Study Arms (3)

A

EXPERIMENTAL

Drug: activated recombinant human factor VII, long acting

B

EXPERIMENTAL

Drug: activated recombinant human factor VII, long acting

C

EXPERIMENTAL

Drug: activated recombinant human factor VII, long acting

Interventions

activated recombinant human factor VII, long actingDRUG

After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 25 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months

Also known as: NN7128, LA-rFVIIa

Eligibility Criteria

Age12 Years - 65 Years

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Male haemophilia A or B patients with inhibitors
Willing to undergo a bleeding preventive regimen of 3 months' duration and a total trial length of approximately 8 months
Historical or ongoing high titre inhibitor (more than or equal to 5 BU) based on either medical records, laboratory report reviews, patient and/or care provider interviews
At least 2 bleeding episodes requiring bypassing haemostatic-drug-based treatment within the last month or 12 bleeding episodes within the last 6 months prior to observation period
Body weight between 30 and 100 kg (both inclusive)

You may not qualify if:

Body Mass Index (BMI) above 30 kg/m2
Immune tolerance induction therapy within the last month prior to entering observation phase period
Known active pseudo tumours
Platelet count less than 50,000 platelets/microL (based on local laboratory value at screening visit)
Congenital or acquired coagulation disorders other than haemophilia A or B
Surgery within one month prior to the observation period. Catheter, stents and dental extractions do not count as surgeries, i.e. they will not exclude the patient. Port insertion is classified as surgery
Scheduled major and/or orthopaedic surgery, during the trial period until Follow up visit. Catheter, stents and dental extractions do not count as surgeries and will not exclude the patient. Port insertion is classified as surgery
Advanced atherosclerotic disease (i.e. known history of ischemic heart disease, or ischemic stroke)
Any clinical signs or known history of thromboembolic events incl. known deep vein thrombosis (DVT)
Known or clinically suspected allergy to activated recombinant human factor VII (NovoSeven®/NovoSeven RT®/Niastase®)
Prothrombin Time (PT) prolongation (30% above normal limits, or more than 5 seconds compared to control or International Normalised Range (INR) more than 1.7 as defined by local laboratory ranges at screening visit
Severe liver disease (ALAT more than 4 times of the upper limit of normal reference range) (as defined by local laboratory ranges) within a year of enrolment or at the screening
Clinical signs of renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to local laboratory range at the screening visit)
Dosing of any investigational drug within the last 30 days prior to the present trial
Any disease or condition which, according to the investigator's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
+2 more criteria

Contact the study team to confirm eligibility.