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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Trial Summary
Trial Overview
Inclusion Criteria

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
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