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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00951405
Other study ID # NN7128-1907
Secondary ID 2008-006424-54Ja
Status Completed
Phase Phase 2
First received
Last updated
Start date September 1, 2009
Est. completion date March 29, 2011

Study information

Verified date September 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date March 29, 2011
Est. primary completion date March 29, 2011
Accepts healthy volunteers No
Gender Male
Age group 12 Years to 65 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

- HIV positive patients who either have low CD4+ lymphocyte count ( 200/microL or less based on medical records within 6 months or laboratory screening at screening visit), or who are HCV-PCR positive (based on medical records), or who both have low CD4+ lymphocyte count (200/microL or less) and are HCV-PCR positive. If HCV-PCR testing is not locally available, a HIV positive patient who is HCV antibody positive cannot be included

- Need to use other PEGylated pharmaceutical drug during the trial period

Study Design


Intervention

Drug:
activated recombinant human factor VII, long acting
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
activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 100 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 200 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months

Locations

Country Name City State
Brazil Novo Nordisk Investigational Site Rio de Janeiro
Former Serbia and Montenegro Novo Nordisk Investigational Site Belgrade
France Novo Nordisk Investigational Site Le Kremlin Bicetre
France Novo Nordisk Investigational Site Paris
Japan Novo Nordisk Investigational Site Kashihara-shi, Nara
Japan Novo Nordisk Investigational Site Kitakyusyu, Fukuoka
Japan Novo Nordisk Investigational Site Nishinomiya-shi
Japan Novo Nordisk Investigational Site Shinjuku-ku, Tokyo
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Serbia Novo Nordisk Investigational Site Belgrade
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Parktown Johannesburg Gauteng
Sweden Novo Nordisk Investigational Site Malmö
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Istanbul
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Oxford
United States Novo Nordisk Investigational Site Boston Massachusetts
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Little Rock Arkansas
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Orange California
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Brazil,  Former Serbia and Montenegro,  France,  Japan,  Malaysia,  Serbia,  South Africa,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thrombogenecity at all scheduled visits (1 - 9)
Primary Immunogenecity: Neutralising Antibody Development at all scheduled visits (1 - 9)
Secondary 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
Secondary 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
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