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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. |
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Register:
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EUCTR |
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Last refreshed on:
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13 October 2020 |
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Main ID: |
EUCTR2004-000219-24-GB |
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Date of registration:
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18/04/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A multicentre study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital haemophilia A who develop de novo factor VIII inhibitors while receiving factor VIII infusion therapy - N/A
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Scientific title:
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A multicentre study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital haemophilia A who develop de novo factor VIII inhibitors while receiving factor VIII infusion therapy - N/A |
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Date of first enrolment:
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28/04/2005 |
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Target sample size:
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27 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000219-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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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):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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Germany
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Italy
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inhibitor positive hemophilia A patients:
1. Written informed consent or assent, as applicable.
2. Patients with moderate or severe congenital hemophilia A (FVIII:C <5%) .
3. Patients with at least one positive de novo* inhibitor result (> the upper limit of normal as defined by the laboratory performing the assay), attributable by the Investigator to the patient’s current FVIII product, at the time of study visit and a positive inhibitor result confirmed by the central laboratory.
4. Patients with exposure to at least two different FVIII products during their lifetime.
5. Patients with > 50 cumulative ED to FVIII products.
6. Patients able to comply with a 72-hour FVIII washout period.
*de novo inhibitor is defined as no known history of FVIII inhibitor titer.
Comparison group (inhibitor-free patients):
1. Written informed consent / assent, as applicable.
2. Patients with moderate or severe congenital hemophilia A (FVIII:C < 5%).
3. Patients with exposure to at least two different FVIII products during their lifetime.
4. Patients with > 50 cumulative exposure days to FVIII products.
5. Documented negative FVIII BIA at the time of the study visit (< the upper limit of normal as defined by the laboratory performing the assay).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Inhibitor positive hemophilia A patients:
1. Patients with a negative FVIII inhibitor result (< or equal to the upper limit of normal as defined by the laboratory performing the assay) at the study visit.
2. Patients with known history of an inhibitor (> the upper limit of normal as defined by the laboratory performing the assay) prior to their current inhibitor.
3. Patients who have not had at least 1 FVIII BIA performed during the last 5 years prior to their visit for this study.
4. Patients who have received FVIII immune tolerance therapy at any time.
5. Patients, who as of the study visit, have taken only one FVIII product during their lifetime.
6. For patients whose current inhibitor is attributable to treatment with ReFacto; treatment with ReFacto prior to their previous product. In other words patients who were previously treated with ReFacto, then switched to another product, then switched back to ReFacto.
7. Patients with immune disorders (e.g., HIV, myeloma, lymphoma).
Comparison group (inhibitor-free patients):
1. Patients with a positive FVIII inhibitor result (> the upper limit of normal as defined by the laboratory performing the assay) at the time of the study visit.
2. Patients with a prior history of FVIII inhibitor (> the upper limit of normal as defined by the laboratory performing the assay).
3. Patients with immune disorders (e.g., HIV, myeloma, lymphoma).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Haemophilia A is an X-linked recessive clotting disorder in which the clotting factor, factor VIII (FVIII), is deficient or inactive. Patients with low levels of FVIII have an increased tendency to bleed and is characterised by recurrent haemorrhages due to trauma, surgery or spontaneous haemorrhaging when the condition is severe.
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Intervention(s)
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Trade Name: ReFacto
Product Name: ReFacto
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: moroctocog alfa
Other descriptive name: recombinant coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 250, 500, 1000, -2000
Trade Name: Advate
Product Name: Advate
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Octocog alfa
Other descriptive name: Recombinant human coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 250, 500, 1000, -1500
Trade Name: Kogenate Bayer
Product Name: Kogenate Bayer
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: octocog alfa
Other descriptive name: recombinant coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 250, 500, 1000 -
Trade Name: Helixate NexGen
Product Name: Helixate NexGen
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: octocog alfa
Other descriptive name: recombinant coagulation factor VIII
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 250, 500-
Trade Name: Recombinate
Product Name: Recombinate
Pharmaceutical Form: Powder and solvent for solution for injection
Other descriptive name: antihaemophilic factor (recombinant)
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 250, 500, 1000-
Trade Name: Replenate
Product Name: Replenate
Pharmaceutical Form: Powder and solvent for solution for injection
Other descriptive name: human factor VIII
Concentration unit: IU international unit(s)
Concentration t
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Primary Outcome(s)
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Primary end point(s): The endpoint will be a descriptive presentation of epitope regions of FVIII in samples from the three patient groups, using the methodology described in the protocol.
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Main Objective: To describe the patterns of antibodies and associated epitopes in a subset of patients with hemophilia A, who meet the protocol entry criteria, using the methodology described in the protocol.
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Secondary Objective: N/A
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Secondary ID(s)
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N/A
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3082A-101342
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 05/02/2005
Contact:
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