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A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population With Severe Hemophilia A
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
84
19 countries
37
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to \< 12 years of age and at least 25 subjects \< 6 years of age who have undergone \> 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 19, 2014
Actual (reported)March 21, 2014
Actual (reported)August 2015
Actual (reported)August 2015
Actual (reported)January 27, 2017
Actual (reported)Treatment Success
Rate of treatment success where treatment success of a bleeding episode is defined as a rating of "excellent" or "good" based on the investigator's overall clinical assessment of hemostatic efficacy (using a 4-point scale of excellent, good, moderate or poor/no response) on the on-demand and prophylaxis regimens combined. The rate of success was based on the number of treated bleeding events; there were 347 treated bleeding events in the Efficacy Population.
Up to 1 year
Annualized Bleeding Rate
Up to 1 year
Percentage of Bleeding Episodes Requiring 1, 2, 3, or More Than 3 Infusions of rVIII-SingleChain to Achieve Hemostasis.
Up to 1 year
Consumption of rVIII-SingleChain - IU/kg Per Subject Per Month
Up to 1 year
Consumption of rVIII-SingleChain - IU/kg Per Subject Per Year
Up to 1 year
Consumption of rVIII-SingleChain - IU/kg Per Bleeding Event
Up to 1 year
Subjects will be assigned to either an on-demand or prophylaxis regimen and will receive rVIII-SingleChain as an intravenous (IV) infusion. Subjects assigned to a prophylaxis regimen will be treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose for on-demand treatment of a bleeding episode is based on the recommendations of the World Federation of Hemophilia (WFH), with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects will receive a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Study Site
Aurora, Colorado, 80045, United States
Study Site
Chicago, Illinois, 60612, United States
Study Site
Melbourne, Victoria, 3052, Australia
Study Site
Linz, 4020, Austria
Study Site
Vienna, 1090, Austria
Study Site
Brest, 29609, France
Study Site
Le Kremlin-Bicêtre, 94270, France
Program Director
CSL Behring
84 participants (actual enrollment reported by the registry).
First Submitted
March 19, 2014
First Posted
March 21, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Site
Lille, 59037, France
Study Site
Nantes, 44093, France
Study Site
Paris, 75015, France
Study Site
Tbilisi, 0177, Georgia
Study Site
Bonn, 53127, Germany
Study Site
Bremen, 28177, Germany
Study Site
Frankfurt am Main, 60590, Germany
Study Site
Hanover, 30159, Germany
Study Site
Milan, 20122, Italy
Study Site
Beirut, 11072240, Lebanon
Study Site
Kuala Lumpur, 50400, Malaysia
Study Site
Amsterdam, 1105 AZ, Netherlands
Study Site
Njmegen, 6525 GA, Netherlands
Study Site
Utrecht, 3584 CX, Netherlands
Study Site
Cebu City, 6000, Philippines
Study Site
Davao City, 8000, Philippines
Study Site
Rzeszów, 35-310, Poland
Study Site
Porto, 4202-451, Portugal
Study Site
Timișoara, 300011, Romania
Study Site
Madrid, 28046, Spain
Study Site
Lucerne, 6000, Switzerland
Study Site
Bangkok, 10330, Thailand
Study Site
Bangkok, 10700, Thailand
Study Site
Chiang Mai, 50200, Thailand
Study Site
Khon Kaen, 40002, Thailand
Study Site
Songkhla, 90110, Thailand
Study Site
Adana, 01330, Turkey (Türkiye)
Study Site
Istanbul, 34098, Turkey (Türkiye)
Study Site
Izmir, 35100, Turkey (Türkiye)
Study Site
Lviv, 79044, Ukraine
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
January 27, 2017
Results First Posted
January 27, 2017
Record last verified: 2016-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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