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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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8 October 2021 |
Main ID: |
EUCTR2005-001579-37-FR |
Date of registration:
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08/11/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
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Scientific title:
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An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery |
Date of first enrolment:
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13/12/2006 |
Target sample size:
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50 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001579-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
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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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Austria
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France
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: - Male subjects with hemophilia A- FVIII:C = 2% - Age = 12 years - A negative FVIII inhibitor at both the local laboratory and central laboratory at screening - A negative past medical history of a FVIII inhibitor - Previously treated with = 150 exposure days to any Factor VIII product - The subject will be undergoing elective major surgery that is anticipated to require FVIII infusions and daily FVIII activity monitoring over a period of at least 6 days following surgery - ALT (SGOT) and AST (SGPT) =5.0 x ULN, and bilirubin =2mg/dL (33 µmol/L) - Serum albumin = LLN- Serum creatinine =1.25 x ULN- Platelet count = 100,000 /µL - Absolute CD4 count >200 µL - PT =1.25 x ULN or INR = 1.5 - Patients receiving therapy for HIV or Hepatitis infection, must be on a stable antiviral regimen at the time of study entry - The patient should be able to comply with the mandatory 72-hour washout period as specified in the protocol - The patient should be able to comply with the required inpatient length of stay including at least 2 days for BI subjects and at least 6 days for all CI subjects The Global Medical Monitor should be consulted about prospective subjects with complex clinical or laboratory histories relevant to inclusion criteria. Are the trial subjects under 18? no 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: - A history of FVIII inhibitor (clinical or laboratory based assessment, as defined in the protocol definitions), such as recurrent low titer values. Any measured Bethesda inhibitor titer greater than or equal to 0.6 BU/mL, regardless of the laboratory normal range, or any measured Bethesda inhibitor titer greater than the upper limit of normal for the laboratory performing the assay - Presence of a bleeding disorder in addition to hemophilia A - Treatment with any investigational drug or device within the past 30 days, except for subjects entering from other studies of ReFacto AF - Prior participation in this study (except for screen failures) - Regular (e.g. daily, QOD) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain NSAIDs - Concomitant therapy with immunosuppressive drugs (e.g., IVIG, routine systemic corticosteroids) - Known hypersensitivity to hamster protein - Unwilling or unable to follow the terms of the protocol The Global Medical Monitor should be consulted about prospective subjects with complex clinical or laboratory histories relevant to exclusion criteria.
Age minimum:
Age maximum:
Gender:
Female: no Male: yes
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Health Condition(s) or Problem(s) studied
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Male subjects with hemophilia A (FVIII:C =2% confirmed at screening), previously treated with = 150 exposure days to any Factor VIII product, undergoing elective major surgery that is anticipated to require FVIII infusions over a period of at least 6 days following surgery MedDRA version: 8.1
Level: LLT
Classification code 10053751
Term: Hemophilia A with anti factor VIII
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Intervention(s)
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Product Name: ReFacto AF Product Code: 3082B2 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: moroctocog alfa CAS Number: 284036/24/4 Current Sponsor code: 3082B2 Other descriptive name: Albumin-Free Factor VIII Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 500-
Product Name: ReFacto AF Product Code: 3082B2 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: moroctocog alfa CAS Number: 284036/24/4 Current Sponsor code: 3082B2 Other descriptive name: Albumin-Free Factor VIII Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1000-
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Primary Outcome(s)
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Primary end point(s): Efficacy: Assessment of hemostatic efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale below: a) Excellent – Achieved hemostasis comparable to that expected after similar surgery in a non-hemophilic subject b) Good – Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non-hemophilic subject c) Moderate – Obviously delayed hemostasis, but manageable with additional infusions of FVIII d) None – No hemostatic response Safety: evaluations will include routine physical and laboratory examinations, including assessment for FVIII inhibitor development, thrombosis and allergic reactions. All adverse events will be recorded
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Main Objective: Demonstration of the safety and efficacy of ReFacto AF administered by bolus injection or continuous infusion during the perioperative management of patients with hemophilia A undergoing major surgery
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Secondary Objective: - Characterize and compare the total and daily dose of ReFacto AF for both bolus injection and continuous infusion - Characterize the pharmacokinetics of ReFacto AF in the patient population - Characterize the pharmacokinetic measurements required for surgical prophylaxis - Characterize the predicted and estimated actual blood loss and transfusion requirements in the study patient population - Characterize the variety of regimens used in those patients treated by continuous infusion - Characterize patient compliance with prescribed regimens in the outpatient setting
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Secondary ID(s)
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3082B2-311-WW
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2005-001579-37-SE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 13/12/2006
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