Trial Condition(s):

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 (SPINART)

Bayer Identifier:

12800

ClinicalTrials.gov Identifier:

NCT00623480

EudraCT Number:

2008-000985-21

Study Completed

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.

Inclusion Criteria
- Males aged 12 to 50 years (US and Argentina)
 - Males aged 18 to 50 years (other countries)
 - Subjects with severe hemophilia A (<1% FVIII:C) as confirmed by the central lab from a sample obtained at least 96 hours after FVIII administration wash-out. Allow for the inclusion of a maximum of 10% (n=8) of patients with 1-2% FVIII:C baseline levels as long as they exhibit clinical severity and comply with all other inclusion criteria.
 - Subjects with at least 150 prior exposure days with any FVIII
 - Subjects who have been on episodic treatment and no known regular prophylaxis treatment for more than 12 consecutive months in the previous 5 years
 - Subjects with 6 to 24 bleeding events and/or treatments in the previous 6 months prior to study entry which are documented and available in the subjects medical records. Documentation can include records from previous physicians, specific home treatment records, emergency room or hospital records, x-ray reports, etc. The investigator can also document with a detailed note the number of bleeds reported by the subject in the last 6 months.
 - Subjects with inhibitor formation surveillance (inhibitor or recovery testing) over the ten years prior to enrollment documented by the investigator and who do not have a history of any of the following:
 -- A positive inhibitor titer of 5.0 Bethesda Unit (BU) or greater by either BU assay system at any time since first exposure to exogenous factor VIII
 -- A positive inhibitor test result of 1.0 or greater performed by the original BU assay at any time in the past 10 years (A subject can have more than one positive inhibitor test of 0.6 or greater by the original BU assay test but all must be less than 1.0 BU using the original BU assay.)
 -- A positive inhibitor test result of 0.6 or greater performed by the Nijmegen method at any time in the past 10 years
 - Subjects with no inhibitor activity by Nijmegen-modified Bethesda assay, either positive (> 0.6 BU is considered positive) or borderline (> 0.3 and < 0.6 BU is considered borderline) as measured in the current study reference laboratory
Exclusion Criteria
- Subjects with any other bleeding disease besides hemophilia A (i.e. von Willebrand disease)
 - Subjects with thrombocytopenia (platelets < 100,000/mm3)
 - Subjects with abnormal renal function (Cockcroft-Gault Creatinine Clearance value of 60 mL/min or lower)
 - Subjects with active hepatic disease (Aspartate aminotransferase [AST] or Alanine aminotransferase [ALT] > 5xUpper Limit of Normal (ULN))
 - Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study (the following drugs are however allowed: interferon-a treatment for Hepatitis C virus (HCV), Highly active anti-retroviral therapy (HAART) therapy for human immunodeficiency virus (HIV) and/or a total of two courses of pulse treatment with steroids for a maximum of 7 days at 1mg/kg or less)
 - Subjects with an absolute CD4 lymphocyte cell count < 200 cells/mm3 (due to HIV, HCV or another suspected medical condition)
 - Subjects with known hypersensitivity to rFVIII, mouse or hamster proteins
 - Subjects who are receiving or had received other experimental drugs within 1 month prior to study entry
 - Subjects who require any pre-medication to tolerate FVIII injections (e.g. anti-histamines)
 - Subjects who are unwilling to comply with study visits or either of the possible treatment regimens
 - Subjects who have a planned orthopedic intervention to be performed during the study that may substantially affect bleeding (e.g. surgical or chemical or radiological  synovectomy)
 - Subjects who are not suitable for participation in this study for any reason, according to the Investigator 
 - Subjects who have poor joint status as defined by routine need for a wheelchair or unable to ambulate without the assistance of a brace, cane or crutches
 - Three or more joints that are already fused or "frozen" also called ankylosis

Trial Summary

Enrollment Goal
84
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hemophilia Treatment Center of Las Vegas

Las Vegas, United States, 89109-2803

Status
Completed
 
Locations

Comprehensive Center for Bleeding Disorders

Milwaukee, United States, 53226

Status
Completed
 
Locations

University of Minnesota Medical Center-Fairview

Minneapolis, United States, 55455

Status
Completed
 
Locations

Mountain States Regional Hemophilia & Thrombosis Center

Aurora, United States, 80045

Status
Completed
 
Locations

Children's Hospital of Orange County

Orange, United States, 92868

Status
Completed
 
Locations

Arkansas Children's Hospital

Little Rock, United States, 72202

Status
Completed
 
Locations

Mount Sinai Medical Center

New York, United States, 10029

Status
Completed
 
Locations

Rush University Medical Center

Chicago, United States, 60612

Status
Terminated
 
Locations

Hemophilia Center of Western Pennsylvania

Pittsburgh, United States, 15213

Status
Completed
 
Locations

University of Iowa Hospitals & Clinics

Iowa City, United States, 52242-1089

Status
Completed
 
Locations

Northwestern University

Chicago, United States, 60611

Status
Completed
 
Locations

Children's Hospital of Michigan

Detroit, United States, 48201-2196

Status
Terminated
 
Locations

University of Louisville

Louisville, United States, 40202

Status
Completed
 
Locations

University of California - Davis

Sacramento, United States, 95817

Status
Terminated
 
Locations

Gulf States Hemophilia & Thrombophilia Center

Houston, United States, 77030

Status
Completed
 
Locations

New York-Presbyterian Hospital

New York, United States, 10065

Status
Completed
 
Locations

Emory University

Atlanta, United States, 30322

Status
Completed
 
Locations

Riley Hospital For Children

Indianapolis, United States, 46260

Status
Completed
 
Locations

Georgetown University Medical Center

Washington, United States, 20007-2197

Status
Terminated
 
Locations

Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033-0850

Status
Completed
 
Locations

Brigham & Women's Hospital

Boston, United States, 02115

Status
Terminated
 
Locations

Newark Beth Israel Medical Center

Newark, United States, 07112

Status
Completed
 
Locations

University of Arizona Health Science Center

Tucson, United States, 85724

Status
Completed
 
Locations

University of Tennessee Medical Center

Knoxville, United States, 37920

Status
Completed
 
Locations

Nemour's Children's Clinic - Orlando

Orlando, United States, 32801

Status
Completed
 
Locations

Children's Mercy Hospital

Kansas City, United States, 64108

Status
Completed
 
Locations

MHAT Sveta Marina EAD

Varna, Bulgaria, 9010

Status
Completed
 
Locations

Hospital Ramos Mejía

Buenos Aires, Argentina, C1221 ADC

Status
Completed
 
Locations

University Hospitals Case Medical Center

Cleveland, United States, 44106

Status
Completed
 
Locations

University of Utah

Salt Lake City, United States, 84132

Status
Completed
 
Locations

Specialized Hospital for Active Treatment of Oncology

Sofia, Bulgaria, 1756

Status
Completed
 
Locations

UMHAT "Sveti Georgi"

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Instituto de Hematología Dr. Rubén Dávoli

Rosario, Argentina, S2000CKF

Status
Completed
 
Locations

S.C. SANADOR SRL

Bucharest, Romania, 11026

Status
Completed
 
Locations

Constanta Clinical Country Emergency Hospital

Constanta, Romania, 900591

Status
Completed
 
Locations

Clinical Emergency Hospital for Children "Louis Turcanu"

Timisoara, Romania, 300011

Status
Terminated
 
Locations

Fundeni Clinical Institute

Bucharest, Romania, 022328

Status
Completed
 
Locations

Clinical Emergency County Hospital Brasov

Brasov, Romania, 50035

Status
Terminated
 

Trial Design