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Monoclonal Antibodies

Cohort 2: ALXN1830 for Autoimmune Hemolytic Anemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 5 minutes, 2, 4, 6, 24, and 48 hours, and 5 days postdose
Awards & highlights

Summary

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

Eligible Conditions
  • Autoimmune Hemolytic Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 5 minutes, 2, 4, 6, 24, and 48 hours, and 5 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 5 minutes, 2, 4, 6, 24, and 48 hours, and 5 days postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Count Of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Change From Baseline In Hemoglobin At Day 33
Change From Baseline In Reticulocyte Count At Day 33
Immunogenicity Of ALXN1830 At Day 112, As Assessed By Anti-ALXN1830 Antibody Level
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: ALXN1830Experimental Treatment1 Intervention
SYNT001 Dose 2
Group II: Cohort 1: ALXN1830Experimental Treatment1 Intervention
SYNT001 Dose 1

Find a Location

Who is running the clinical trial?

Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,348 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
257 Previous Clinical Trials
41,057 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
39,262 Total Patients Enrolled
~1 spots leftby Sep 2025
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