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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00951405
Collaborator
(none)
23
Enrollment
25
Locations
3
Arms
18.9
Actual Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: activated recombinant human factor VII, long acting
  • Drug: activated recombinant human factor VII, long acting
  • Drug: activated recombinant human factor VII, long acting
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Mar 29, 2011
Actual Study Completion Date :
Mar 29, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

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
Other Names:
  • NN7128
  • LA-rFVIIa

    		•
    Experimental: B

    Drug: 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
    Other Names:
  • NN7128
  • LA-rFVIIa

    		•
    Experimental: C

    Drug: 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
    Other Names:
  • NN7128
  • LA-rFVIIa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Thrombogenecity [at all scheduled visits (1 - 9)]

    2. Immunogenecity: Neutralising Antibody Development [at all scheduled visits (1 - 9)]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Little Rock Arkansas United States 72202
    2 Novo Nordisk Investigational Site Los Angeles California United States 90027
    3 Novo Nordisk Investigational Site Orange California United States 92868
    4 Novo Nordisk Investigational Site Tampa Florida United States 33607
    5 Novo Nordisk Investigational Site Boston Massachusetts United States 02115
    6 Novo Nordisk Investigational Site Portland Oregon United States 97239
    7 Novo Nordisk Investigational Site Hershey Pennsylvania United States 17033
    8 Novo Nordisk Investigational Site Rio de Janeiro Brazil 20211-030
    9 Novo Nordisk Investigational Site Belgrade Former Serbia and Montenegro 11000
    10 Novo Nordisk Investigational Site Le Kremlin Bicetre France 94270
    11 Novo Nordisk Investigational Site Paris France 75015
    12 Novo Nordisk Investigational Site Kashihara-shi, Nara Japan 634 8522
    13 Novo Nordisk Investigational Site Kitakyusyu, Fukuoka Japan 807 8555
    14 Novo Nordisk Investigational Site Nishinomiya-shi Japan 663 8051
    15 Novo Nordisk Investigational Site Shinjuku-ku, Tokyo Japan 160 0023
    16 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 50400
    17 Novo Nordisk Investigational Site Belgrade Serbia 11000
    18 Novo Nordisk Investigational Site Parktown Johannesburg Gauteng South Africa 2193
    19 Novo Nordisk Investigational Site Durban KwaZulu-Natal South Africa 4013
    20 Novo Nordisk Investigational Site Malmö Sweden 205 02
    21 Novo Nordisk Investigational Site Ankara Turkey 06500
    22 Novo Nordisk Investigational Site Istanbul Turkey 34098
    23 Novo Nordisk Investigational Site London United Kingdom NW3 2QG
    24 Novo Nordisk Investigational Site London United Kingdom SE1 7EH
    25 Novo Nordisk Investigational Site Oxford United Kingdom OX3 7LJ

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT00951405
    Other Study ID Numbers:
    • NN7128-1907
    • 2008-006424-54
    • JapicCTI-090860
    • U1111-1111-8584
    First Posted:
    Aug 4, 2009
    Last Update Posted:
    Sep 5, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Hemostatic Disorders
    Hemophilia A
    Hemophilia B
    Blood Coagulation Disorders

    Study Results

    No Results Posted as of Sep 5, 2018