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A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)

Warm Autoimmune Hemolytic Anemia Clinical Trial

Official title:
A Phase 1B/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)

Clinical Trial Summary

This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.

Clinical Trial Description

This study planned to evaluate 2 cohorts: Cohort 1, up to 8 participants to receive IV doses of ALXN1830 (SYNT001 Dose 1); Cohort 2, up to 12 participants to receive IV doses of ALXN1830 (SYNT001 Dose 2).

This study was terminated after the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy were characterized in participants with WAIHA in Cohort 1 (SYNT001 Dose 1), before any participants were enrolled in Cohort 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03075878
Study type Interventional
Source Alexion Pharmaceuticals
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date January 10, 2018
Completion date August 6, 2019
View Details
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