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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2019-08-06

Brief Summary

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

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Detailed Description

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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.

Conditions

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Warm Autoimmune Hemolytic Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: ALXN1830

SYNT001 Dose 1

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

Administered via IV infusion.

Cohort 2: ALXN1830

SYNT001 Dose 2

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

Administered via IV infusion.

Interventions

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ALXN1830

Administered via IV infusion.

Intervention Type DRUG

Other Intervention Names

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SYNT001

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No