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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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)

Brief 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.

Detailed Summary:
Sponsor: Syntimmune, Inc.

Current Primary Outcome: Assessment of safety data (counts and percentages of adverse events) [ Time Frame: Day 0 - Day 56 ]

counts and percentages of adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Syntimmune, Inc.

Dates:
Date Received: March 3, 2017
Date Started: April 2017
Date Completion: March 2018
Last Updated: April 25, 2017
Last Verified: April 2017