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 |
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.
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
9
sites
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1441 Eastlake Ave
Los Angeles, California 90033
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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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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505 Parnassus Avenue
San Francisco, California 94143
San Francisco, California 94143
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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