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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Anemia, Hemolytic, Autoimmune Anemia Hemolysis Anemia, Hemolytic

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • University of California San Francisco - Outpatient Hematology Clinic/Infusion Center accepting new patients
    San Francisco, California, 94143, United States
  • USC - Norris Comprehensive Cancer Center accepting new patients
    Los Angeles, California, 90033, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Syntimmune, Inc.
ID
NCT03075878
Phase
Phase 1
Lead Scientist
Andrew Leavitt
Study Type
Interventional
Last Updated
October 31, 2017
I’m interested in this study!