A Safety Study of SYNT001 in Subjects With Chronic, Stable Warm Autoimmune Hemolytic Anemia (WAIHA)



Status:Recruiting
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 10, 2018
End Date:January 2019
Contact:Syntimmune, Inc
Email:SYNT001Clinical@syntimmune.com
Phone:617-947-8038

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A Phase 1b, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Subjects With Chronic, Stable Warm Autoimmune Hemolytic Anemia (WAIHA)

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia
(WAIHA) disease activity markers of intravenous (IV) SYNT001.


Inclusion Criteria:

Subjects must meet the following criteria to be included:

- Willing and able to read, understand and sign an informed consent form

- Confirmed diagnosis by enrolling physician of WAIHA

- Must use medically acceptable contraception

Exclusion Criteria:

Subjects meeting any of the following criteria are to be excluded:

- Subject unable or unwilling to comply with the protocol

- Active non-hematologic malignancy or history of non-hematologic malignancy in the 3
years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in
situ)

- Positive for HIV or hepatitis C antibody

- Positive for hepatitis B surface antigen

- Any exposure to an investigational drug or device within the 30 days prior to
screening

- IVIG treatment within 60 days of screening

- Plasmapheresis or immunoadsorption within 60 days of screening

- Subject has any current medical condition that, in the opinion of the Investigator,
may compromise their safety or compliance, preclude successful conduct of the study,
or interfere with interpretation of the results
We found this trial at
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2010 E 90th St
Cleveland, Ohio 44195
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Pittsburgh, Pennsylvania 15232
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Pittsfield, Massachusetts 01201
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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1959 NE Pacific St
Seattle, Washington 98195
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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