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
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
2 other identifiers
interventional
84
4 countries
38
Brief Summary
To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding frequency (number of bleeds per year) and on joint damage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2008
Longer than P75 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedResults Posted
Study results publicly available
August 7, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 17, 2014
November 1, 2014
3.5 years
February 4, 2008
May 2, 2013
November 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding Frequency (Number of Total Bleeds)
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)
Secondary Outcomes (2)
Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.
Baseline and 3 years
Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale
Baseline and 3 years
Other Outcomes (1)
Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A
Baseline and 3 years
Study Arms (2)
Recombinant Factor VIII prophylaxis treatment
EXPERIMENTALParticipants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Recombinant Factor VIII on-demand treatment
EXPERIMENTALParticipants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
Interventions
Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Eligibility Criteria
You may qualify if:
- Males aged 12 to 50 years (US and Argentina)
- Males aged 18 to 50 years (other countries)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (38)
Unknown Facility
Tucson, Arizona, 85724, United States
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Washington D.C., District of Columbia, 20007-2197, United States
Unknown Facility
Orlando, Florida, 32801, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Iowa City, Iowa, 52242-1089, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Detroit, Michigan, 48201-2196, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Kansas City, Missouri, 64108, United States
Unknown Facility
Las Vegas, Nevada, 89109-2803, United States
Unknown Facility
Newark, New Jersey, 07112, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Hershey, Pennsylvania, 17033-0850, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Unknown Facility
Buenos Aires, Ciudad Auton. de Buenos Aires, C1221 ADC, Argentina
Unknown Facility
Rosario, Santa Fe Province, S2000CKF, Argentina
Unknown Facility
Plovdiv, 4002, Bulgaria
Unknown Facility
Sofia, 1756, Bulgaria
Unknown Facility
Varna, 9010, Bulgaria
Unknown Facility
Timișoara, Timiș County, 300011, Romania
Unknown Facility
Brasov, 50035, Romania
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Bucharest, 11026, Romania
Unknown Facility
Constanța, 900591, Romania
Related Publications (2)
Manco-Johnson MJ, Kempton CL, Reding MT, Lissitchkov T, Goranov S, Gercheva L, Rusen L, Ghinea M, Uscatescu V, Rescia V, Hong W. Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant factor VIII in adults with severe hemophilia A (SPINART). J Thromb Haemost. 2013 Jun;11(6):1119-27. doi: 10.1111/jth.12202.
PMID: 23528101RESULTManco-Johnson MJ, Lundin B, Funk S, Peterfy C, Raunig D, Werk M, Kempton CL, Reding MT, Goranov S, Gercheva L, Rusen L, Uscatescu V, Pierdominici M, Engelen S, Pocoski J, Walker D, Hong W. Effect of late prophylaxis in hemophilia on joint status: a randomized trial. J Thromb Haemost. 2017 Nov;15(11):2115-2124. doi: 10.1111/jth.13811. Epub 2017 Oct 10.
PMID: 28836341DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 26, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2011
Study Completion
November 1, 2013
Last Updated
November 17, 2014
Results First Posted
August 7, 2013
Record last verified: 2014-11