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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00486278
Other study ID # NN1731-1804
Secondary ID 2006-004879-35CT
Status Completed
Phase Phase 2
First received June 13, 2007
Last updated April 15, 2015
Start date June 2007
Est. completion date June 2010

Study information

Verified date April 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaBrazil: National Health Surveillance AgencyCanada: Health CanadaCroatia: Ministry of Health and Social CareHungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: The Italian Medicines AgencyJapan: Ministry of Health, Labour and Welfare (MHLW)Malaysia: Drug Control Authority (DCA)Poland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical TrialsSouth Africa: Medicines Control CouncilSpain: Spanish Drug Agency and Medicinal ProductsTaiwan: Department of HealthThailand: Ministry of Public HealthTurkey: Ministry of Health Drug and Pharmaceutical DepartmentUnited Kingdom: Medicines and Healthcare Products RegulatoryUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility Inclusion Criteria:

- 12 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
eptacog alfa (activated)
90 mcg/kg, injected i.v.
vatreptacog alfa (activated)
5 mcg/kg, injected i.v.
vatreptacog alfa (activated)
10 mcg/kg, injected i.v.
vatreptacog alfa (activated)
20 mcg/kg, injected i.v.
vatreptacog alfa (activated)
40 mcg/kg, injected i.v.
vatreptacog alfa (activated)
80 mcg/kg, injected i.v.

Locations

Country Name City State
United States Novo Nordisk Clinical Trial Call Center Boston Massachusetts
United States Novo Nordisk Clinical Trial Call Center Chapel Hill North Carolina
United States Novo Nordisk Clinical Trial Call Center Chicago Illinois
United States Novo Nordisk Clinical Trial Call Center Indianapolis Indiana
United States Novo Nordisk Clinical Trial Call Center Iowa City Iowa
United States Novo Nordisk Clinical Trial Call Center Los Angeles California
United States Novo Nordisk Clinical Trial Call Center Minneapolis Minnesota
United States Novo Nordisk Clinical Trial Call Center New York New York
United States Novo Nordisk Clinical Trial Call Center Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Croatia,  Hungary,  Israel,  Italy,  Japan,  Malaysia,  Poland,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary Activated Recombinant Human Factor VII Analogue Activity in the Blood 0-24 hours after trial product administration No
Secondary Prothrombin Time (PT) The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity. pre-dose - 12 hours after trial product administration No
Secondary F1 + 2 (Prothrombin Fragments 1+2) Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated. pre-dose - 12 hours after trial product administration No
Secondary Activated Partial Thromboplastin Time (aPTT) The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time. pre-dose - 12 hours after trial product administration No
Secondary 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) No
Secondary Number of Subjects With Need for Additional Haemostatic Agents within 24 hours after successful control of bleeding episode with trial product No
Secondary Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) ) 0-24 hours after trial product administration No
Secondary Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity) 0-24 hours after trial product administration No
Secondary Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time) 0-24 hours after trial product administration No
Secondary Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life) 0-24 hours after trial product administration No
Secondary Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance) 0-24 hours after trial product administration No
Secondary Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State) 0-24 hours after trial product administration No
Secondary Immunogenicity (Inhibitor Development) Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa. Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product. No
Secondary Biochemistry: ALAT (Alanine Aminotransferase) screening visit, pre-dose and 12 hours after dosing No
Secondary Biochemistry: Creatinine screening visit, pre-dose and 12 hours after dosing No
Secondary Haematology: Haemoglobin screening visit, pre-dose and 12 hours after dosing No
Secondary Haematology: Red Cell Count screening visit, pre-dose and 12 hours after dosing No
Secondary Haematology: Packed Cell Volume screening visit, pre-dose and 12 hours after dosing No
Secondary Haematology: White Cell Count screening visit, pre-dose and 12 hours after dosing No
Secondary Haematology: Platelet Count screening visit, pre-dose and 12 hours after dosing No
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