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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Participants had to meet the following criteria to be included: - Willing and able to read, understand, and sign an informed consent form - Confirmed diagnosis of WAIHA by enrolling physician - Must have used medically acceptable contraception

Exclusion Criteria

Participants who met any of the following criteria were excluded: - Participant 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 human immunodeficiency virus 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 - Intravenous immunoglobulin treatment within 30 days of screening - Plasmapheresis or immunoadsorption within 30 days of screening - Participant had any current medical condition that, in the opinion of the Investigator, may have compromised their safety or compliance, precluded successful conduct of the study, or interfered with interpretation of the results

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: ALXN1830 		SYNT001 Dose 1
  • Drug: ALXN1830
    Administered via IV infusion.
    Other names:
    • SYNT001
Experimental
Cohort 2: ALXN1830 		SYNT001 Dose 2
  • Drug: ALXN1830
    Administered via IV infusion.
    Other names:
    • SYNT001

More Details

Status
Terminated
Sponsor
Alexion Pharmaceuticals, Inc.

Study Contact

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.