A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)
Study Identifier:
SYNT001-102
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Available Documents
Study Details
Medical Condition
- Warm Autoimmune Hemolytic Anemia
Study Drug
- Drug: ALXN1830
Date
Jan 2018 - Apr 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
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
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Warm Autoimmune Hemolytic Anemia
Study Drug
- Drug: ALXN1830
Date
Jan 2018 - Apr 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
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
Protocol Summary
This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.
Trial Locations
Location
Status
Location
Alexion Study Site
Los Angeles, California, United States, 90033
Status
N/A
Location
Alexion Study Site
San Francisco, California, United States, 94143
Status
N/A
Location
Alexion Study Site
Boston, Massachusetts, United States, 02114
Status
N/A
Location
Alexion Study Site
Pittsfield, Massachusetts, United States, 01201
Status
N/A
Location
Alexion Study Site
Rochester, Minnesota, United States, 55905
Status
N/A
Location
Alexion Study Site
Cleveland, Ohio, United States, 44106
Status
N/A
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