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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:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-000720-16-SE
Date of registration:	14/07/2005
Prospective Registration:	Yes
Primary sponsor:	Wyeth Research Division of Wyeth Pharmaceuticals, Inc. Clinical Research & Development
Public title:	A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII Preparation (FLrFVIII, Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients with Hemophilia A
Scientific title:	A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII Preparation (FLrFVIII, Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients with Hemophilia A
Date of first enrolment:	19/08/2005
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000720-16
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: Double blind: yes Parallel group: Cross over: yes Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:
Phase:

Countries of recruitment
Belgium	Finland	Germany	Hungary	Italy	Spain	Sweden

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
For all patients participating in the trial:- Male subjects with severe or moderately severe hemophilia A (FVIII:C = 2%) previously treated with = 150 exposure days to any Factor VIII product. - Age = 12 years- 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 >400 µL- PT =1.25 x ULN or INR = 1.5- Patients receiving therapy for HIV or Hepatitis infection, must be on a stable regimen at the time of study entry- The patient is able to comply with the mandatory 72-hour washout period preceding each FVIII:C and FVIII inhibitor assessment during Visit 1, 4, 5, 7 and 10- The patient must sign and date informed consent and/or assent form, approved by the IRB.The Global Medical Monitor should be consulted about prospective subjects with complex clinical or laboratory histories relevant to inclusion criteriaFor patients participating in the pharmacokinetic period of the trial:- Male subjects as described immediately above except they must have a Factor VIII:C of = 1% confrimed by the central laboratory screening test- The patient’s site has the facilities, in the opinion of the Sponsor, adequate to conduct the Pharmacokinetic analysis- The patient should be able to comply with the mandatory 72 hour washout period preceding each PK period of the study during Visit 2, 3 and 10.
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:
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 - Elective surgery planned to occur within an 8 to 9 month period following study entry (i.e., during the course of the study)- 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:
Male: yes

Health Condition(s) or Problem(s) studied

For all patients participating in the trial:Male subjects with severe or moderately severe hemophilia A (FVIII:C = 2%) previously treated with = 150 exposure days to any Factor VIII product.For patients participating in the Pharmacokinetic period of the trial:Male subjects as described immediately above except they must have a Factor VIII:C of = 1%

Intervention(s)

Product Name: ReFacto AF
Product Code: ReFacto AF
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: moroctocog alfa
CAS Number: 284036/24/4
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-

Product Name: ReFacto AF
Product Code: ReFacto AF
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: moroctocog alfa
CAS Number: 284036/24/4
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Advate
Product Name: Advate
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: octocog alfa
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

Secondary Objective: To characterize the efficacy of ReFacto AF in preventing and treating bleeding episodes during prophylaxis treatment;To characterize the pharmacokinetics of ReFacto AF in comparison to Advate and over time;To characterize the efficacy response of both prophylactic and on- demand infusions of ReFacto AF;To characterize the adverse events;To characterize the rate of “Less than Expected Therapeutic Effect” responses of ReFacto AF when used either prophylactically or for treatment of a bleeding episode (“on-demand”) or in the instance of low recovery;To characterize the consumption of ReFacto AF (international units/kg) over time;To characterize the incidence of allergic reactionsTo characterize patient compliance with prescribed regimen(s)

Main Objective: Safety: To determine the incidence rate of Factor VIII inhibitors in the study patient population
Efficacy: To establish the bioequivalence of ReFacto AF with a full-length recombinant Factor VIII (Advate) using the one stage factor VIII activity assay.

Primary end point(s): Determination of the number of Factor VIII inhibitors in the patient populationDetermination of the safety and efficacy of ReFacto AF in the prevention and treatment of bleeding

Secondary Outcome(s)

Secondary ID(s)

2005-000720-16-HU

3082B2-310-WW

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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