A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)



Status:Active, not recruiting
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:July 2016
End Date:June 2019

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A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the
treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).


Inclusion Criteria:

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

- Must have failed at least 1 prior treatment regimen for AIHA.

Exclusion Criteria:

- Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or
paroxysmal cold hemoglobinuria.

- Subject with a platelet count of < 30,000/μL.

- Subject has AIHA secondary to autoimmune disease, including systemic lupus
erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable
or is not well-controlled on current therapy.

- Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood
pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
We found this trial at
32
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: David Kuter, MD
Phone: 617-726-8033
2578
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Irina Murakhovskaya, MD
Phone: 718-920-4137
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-625-6919
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
1511
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Minneapolis, MN
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-4220
University of Utah Research is a major component in the life of the U benefiting...
572
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Salt Lake City, UT
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Seattle, Washington 98104
(206) 543-2100
Phone: 206-685-4489
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Phone: 410-550-1711
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Baltimore, MD
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Bethesda, Maryland 20817
Phone: 240-482-0526
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Bethesda, MD
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Alan Lichtin, MD
Phone: 216-444-6823
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Kerry Rogers, MD
Phone: 614-366-9338
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
1960
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Columbus, OH
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Edmonton, Alberta
Phone: 780-407-6090
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Edmonton,
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Gilbert, Arizona 85234
Phone: 480-256-3333
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Gilbert, AZ
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Greenville, North Carolina 27834
Principal Investigator: Darla Liles, MD
Phone: 252-744-0282
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Greenville, NC
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: Michael Choi, MD
Phone: 858-534-1765
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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Loma Linda, California 92354
Phone: 909-558-4050
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Loma Linda, CA
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Los Angeles, California 90033
Phone: 323-865-3000
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Los Angeles, CA
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4000 Wellness Drive
Midland, Michigan 48640
Phone: 989-839-1716
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Midland, MI
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Milwaukee, Wisconsin 53226
Principal Investigator: Joshua Field, MD
Phone: 414-937-3848
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Milwaukee, WI
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Morgantown, West Virginia 26506
(304) 293-0111
Phone: 740-293-4229
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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Mount Sterling, Kentucky 40353
Phone: 859-499-1000
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Mount Sterling, KY
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New Brunswick, New Jersey 08903
Phone: 732-235-7679
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New Brunswick, NJ
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Orange City, Florida 32763
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Orange City, FL
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Salisbury, North Carolina 28144
Principal Investigator: Elizabeth Agnew, MD
Phone: 704-638-9000
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Salisbury, NC
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Salt Lake City, Utah 84112
Principal Investigator: George M Rodgers III, MD
Phone: 801-213-2016
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Salt Lake City, UT
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San Antonio, Texas 78229
Principal Investigator: Roger Lyons, MD
Phone: 210-595-5626
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San Antonio, TX
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San Francisco, California 94143
Phone: 415-353-2421
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San Francisco, CA
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Sumter, South Carolina 29150
Phone: 803-934-8348
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Sumter, SC
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5200 Harroun Road
Sylvania, Ohio 43560
Phone: 419-824-1011
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Sylvania, OH
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Tucson, Arizona 85745
Principal Investigator: Michael Boxer, MD
Phone: 520-866-0206
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Tucson, AZ
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Washington, District of Columbia 20007
Principal Investigator: Catherine Broome, MD
Phone: 202-444-8240
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Washington,
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Webster, Texas 77598
Phone: 281-724-8335
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Webster, TX
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Whittier, California 90606
Principal Investigator: Richy Agajanian, MD
Phone: 562-693-4477
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Whittier, CA
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