Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2011-001142-15-DE |
Date of registration:
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21/12/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A
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Scientific title:
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A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A - pathfinder™ 2 |
Date of first enrolment:
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10/01/2012 |
Target sample size:
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180 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001142-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Brazil
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Bulgaria
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Croatia
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Denmark
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France
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Germany
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Hungary
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Italy
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Japan
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Korea, Republic of
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Malaysia
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Netherlands
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Norway
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Russian Federation
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Spain
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Sweden
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Switzerland
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Vandtaarnsvej 114, VTB
DK-2860
Soeborg
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Vandtaarnsvej 114, VTB
DK-2860
Soeborg
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Male patients with severe congenital haemophilia A (FVIII activity <1%, according to medical records)
- Documented history of at least 150 EDs to other FVIII products
- Age = 12 years and body weight = 35 kg (except for Croatia, The Netherlands, France, Russia and Israel where the lower age limit will be 18 years) Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 157 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: - Previous participation in this trial defined as withdrawal after administration N8-GP
- Any history of FVIII inhibitors
- FVIII inhibitors = 0.6 BU/mL at screening
- HIV positive, defined by medical records with CD4+ count =200/µL or a viral load of >400000 copies/mL If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit
- Congenital or acquired coagulation disorders other than haemophilia A
- Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records
- Platelet count < 50,000 platelets/µL (laboratory value at the screening visit)
- ALAT > 3 times the upper limit of normal reference ranges at central laboratory
- Creatinine level = 1.5 times above upper normal limit (according to central laboratory reference ranges)
- Ongoing immune modulating or chemotherapeutic medication
Age minimum:
Age maximum:
Gender:
Female: no Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
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Haemophilia A
MedDRA version: 20.0
Level: LLT
Classification code 10018937
Term: Haemophilia A
System Organ Class: 100000004850
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Intervention(s)
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Product Name: N8-GP rFVIII Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: N/A CAS Number: 1309086-46-1 Current Sponsor code: NNC129-1003 Concentration unit: U unit(s) Concentration type: equal Concentration number: 2000-
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Primary Outcome(s)
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Secondary Objective: - To evaluate the clinical efficacy of N8-GP when treating bleeds in patients with haemophilia A - To evaluate the safety of N8-GP when used for prevention of bleeds and treatment of bleeds in patients with haemophilia A - To evaluate PK properties of N8-GP - To evaluate Patient Reported Outcomes - To evaluate the health economic impact of N8-GP treatment - Generation of a population based PK-model for N8-GP
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Timepoint(s) of evaluation of this end point: The endpoints will be analysed based on all available information after approximately 24 and 36 months and until the end of trial (EOT) visit.
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Main Objective: - To evaluate the immunogenicity of NNC 0129-0000-1003 (hereafter referred to as N8-GP) in previously treated patients with Haemophilia A - To evaluate the clinical efficacy of N8-GP in bleeding prophylaxis (number of bleeds during prophylaxis)
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Primary end point(s): - The Incidence rate of FVIII-inhibitors =0.6 BU - Annualised bleeding rate in the prophylaxis arm
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: The endpoints will be analysed based on all available information until the end of trial (EOT) visit and up to approximately 24 and 36 months.
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Secondary end point(s): - Haemostatic effect of N8-GP when used for treatment of bleeds, assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) by counting excellent and good as success and moderate and none as failure.
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Secondary ID(s)
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2011-001142-15-NL
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NN7088-3859
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Source(s) of Monetary Support
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Novo Nordisk A/S
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Ethics review
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Status: Approved
Approval date:
Contact:
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