A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
Study Identifier:
ALXN1007-GIGVHD-201
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Study Details
Medical Condition
- Unmapped
Study Drug
- Biological: ALXN1007 10 mg/kg once weekly
- Biological: ALXN1007 20 mg/kg once weekly
- Biological: ALXN1007 20 mg/kg twice weekly
Date
Nov 2014 - Feb 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Unmapped
Study Drug
- Biological: ALXN1007 10 mg/kg once weekly
- Biological: ALXN1007 20 mg/kg once weekly
- Biological: ALXN1007 20 mg/kg twice weekly
Date
Nov 2014 - Feb 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Protocol Summary
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.
Trial Locations
Location
Status
Location
City of Hope
Duarte, California, United States, 91010
Status
N/A
Location
Emory University Hospital
Atlanta, Georgia, United States, 30322
Status
N/A
Location
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Status
N/A
Location
University of Minnesota Medicine - Hematology, Oncology and Transplantation Office
Minneapolis, Minnesota, United States, 55455
Status
N/A
Location
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Status
N/A
Location
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Status
N/A