check_circleStudy Completed

Hemophilia A

Trial to evaluate the effect of secondary prophylaxis with rFVIII therapy in severe hemophilia A adult and/or adolescent subjects compared to that of episodic treatment

Trial purpose

To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding frequency (number of bleeds per year) and on joint damage.

Key Participants Requirements

Sex

Male

Age

12 - 50 Years

Trial summary

Enrollment Goal
84
Trial Dates
March 2008 - November 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hemophilia Treatment Center of Las VegasLas Vegas, 89109-2803, United States
Completed
Comprehensive Center for Bleeding DisordersMilwaukee, 53226, United States
Completed
University of Minnesota Medical Center-FairviewMinneapolis, 55455, United States
Completed
Mountain States Regional Hemophilia & Thrombosis CenterAurora, 80045, United States
Completed
Children's Hospital of Orange CountyOrange, 92868, United States
Completed
Arkansas Children's HospitalLittle Rock, 72202, United States
Completed
Mount Sinai Medical CenterNew York, 10029, United States
Terminated
Rush University Medical CenterChicago, 60612, United States
Completed
Hemophilia Center of Western PennsylvaniaPittsburgh, 15213, United States
Completed
University of Iowa Hospitals & ClinicsIowa City, 52242-1089, United States
Completed
Northwestern UniversityChicago, 60611, United States
Terminated
Children's Hospital of MichiganDetroit, 48201-2196, United States
Completed
University of LouisvilleLouisville, 40202, United States
Terminated
University of California - DavisSacramento, 95817, United States
Completed
Gulf States Hemophilia & Thrombophilia CenterHouston, 77030, United States
Completed
New York-Presbyterian HospitalNew York, 10065, United States
Completed
Emory UniversityAtlanta, 30322, United States
Completed
Riley Hospital For ChildrenIndianapolis, 46260, United States
Terminated
Georgetown University Medical CenterWashington, 20007-2197, United States
Completed
Penn State Milton S. Hershey Medical CenterHershey, 17033-0850, United States
Terminated
Brigham & Women's HospitalBoston, 02115, United States
Completed
Newark Beth Israel Medical CenterNewark, 07112, United States
Completed
University of Arizona Health Science CenterTucson, 85724, United States
Completed
University of Tennessee Medical CenterKnoxville, 37920, United States
Completed
Nemour's Children's Clinic - OrlandoOrlando, 32801, United States
Completed
Children's Mercy HospitalKansas City, 64108, United States
Completed
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Completed
Hospital Ramos MejíaBuenos Aires, C1221 ADC, Argentina
Completed
University Hospitals Case Medical CenterCleveland, 44106, United States
Completed
University of UtahSalt Lake City, 84132, United States
Completed
Specialized Hospital for Active Treatment of OncologySofia, 1756, Bulgaria
Completed
UMHAT "Sveti Georgi"Plovdiv, 4002, Bulgaria
Completed
Instituto de Hematología Dr. Rubén DávoliRosario, S2000CKF, Argentina
Completed
S.C. SANADOR SRLBucharest, 11026, Romania
Completed
Constanta Clinical Country Emergency HospitalConstanta, 900591, Romania
Terminated
Clinical Emergency Hospital for Children "Louis Turcanu"Timisoara, 300011, Romania
Completed
Fundeni Clinical InstituteBucharest, 022328, Romania
Terminated
Clinical Emergency County Hospital BrasovBrasov, 50035, Romania

Primary Outcome

  • Bleeding Frequency (number of total bleeds)
    date_rangeTime Frame:
    After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change from baseline to 3 years in the MRI (Magnetic resonance imaging) scale.
    The Extended MRI Scale total score has a range between 0 (normal unaffected joint) to 45 (maximal joint damage) points. It is composed of 2 domains, the soft tissue domain with a maximum of 9 points and the osteochondral domain with a maximum of 36 points. A single score for each subject was to be calculated from the sum of both domains and the average over all joints for the Extended MRI endpoint. Higher MRI score denotes greater joint structure damage thus a positive change from baseline means worsening.
    date_rangeTime Frame:
    Baseline and 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline to 3 years in the Colorado Adult Joint Assessment Scale
    The total joint score is derived for each of six joints: left and right sides for knees (score: 0-25), ankles (score: 0-25), and elbows (score: 0-21). Higher CAJAS (Colorado Adult Joint Assessment Scale) score denotes greater joint structure damage thus a positive change from baseline means worsening.
    date_rangeTime Frame:
    Baseline and 3 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Randomized, controlled, parallel, prospective trial to evaluate the effect of secondary prophylaxis with rFVIII therapy in severe hemophilia A adult and/or adolescent subjects, as applicable, compared to that of episodic treatment
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2