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Trial record 2 of 2 for:    SYNT001

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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Syntimmune, Inc.
Sponsor:
Information provided by (Responsible Party):
Syntimmune, Inc.
ClinicalTrials.gov Identifier:
NCT03075878
First received: March 3, 2017
Last updated: August 16, 2017
Last verified: August 2017
  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.

Condition Intervention Phase
Anemia, Hemolytic, Autoimmune Drug: SYNT001 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Syntimmune, Inc.:

Primary Outcome Measures:
  • Assessment of safety data (counts and percentages of adverse events) [ Time Frame: Day 0 - Day 112 ]
    counts and percentages of adverse events


Secondary Outcome Measures:
  • Pharmacokinetics (serum concentration of SYNT001) [ Time Frame: Day 0, 1, 2, 5, 28, 29, 30, 33 ]
    serum concentration of SYNT001

  • Hematocrit [ Time Frame: Day 0, 7, 14, 21, 28, 33, 42, 56, 84, 112 ]
    disease activity marker

  • Hemoglobin [ Time Frame: Day 0, 7, 14, 21, 28, 33, 42, 56, 84, 112 ]
    disease activity marker


Estimated Enrollment: 16
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
SYNT001 Dose 1
Drug: SYNT001
IV in 250 mL over 1 hour administered on Day 0, 7, 14, 21, and 28
Experimental: Cohort 2
SYNT001 Dose 2
Drug: SYNT001
IV in 250 mL over 1 hour administered on Day 0, 7, 14, 21, and 28

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03075878

Contacts
Contact: Syntimmune, Inc 617-913-1681 SYNT001Clinical@syntimmune.com

Locations
United States, Massachusetts
Massachusetts General Hospital - Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic - Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Syntimmune, Inc.
  More Information

Responsible Party: Syntimmune, Inc.
ClinicalTrials.gov Identifier: NCT03075878     History of Changes
Other Study ID Numbers: SYNT001-102
Study First Received: March 3, 2017
Last Updated: August 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia
Hemolysis
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 22, 2017