Clinical Trial Details

NCT ID: NCT03075878
Date Last Changed: October 2, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of SYNT001 to evaluate Anemia, Hemolytic, Autoimmune

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Phase
1
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Syntimmune, Inc.
Duration
3 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

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

Site Locations (6)

Country State City Zip Facility and Contact
United States California Los Angeles 90033 USC - Norris Comprehensive Cancer Center
United States California San Francisco 94143 University of California San Francisco - Outpatient Hematology Clinic/Infusion Center
United States Massachusetts Boston 02114 Massachusetts General Hospital - Cancer Center
United States Minnesota Rochester 55905 Mayo Clinic - Rochester
United States Pennsylvania Philadelphia 19104 Hospital of the University of Pennsylvania
United States Washington Seattle 98195 University of Washington Medical Center

Contact

Syntimmune, Inc
917-415-2210
E-mail:

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