Acute Graft-Versus-Host Disease Clinical Trial
Official title:
A Phase 2A Study of ALXN1007 in Subjects With Newly Diagnosed Acute Graft-Versus-Host Disease Involving the Lower Gastrointestinal Tract
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.
This was a Phase 2A open-label, non-randomized study to evaluate the safety, tolerability, PK/PD, and efficacy of ALXN1007 (a C5a inhibitor) in up to 36 participants with newly diagnosed acute GVHD of the lower GI tract. All participants meeting the inclusion and exclusion criteria for the study were to receive ALXN1007 over an 8 week treatment period. Participants in Cohort 1, the first dosing cohort, were to receive 10 milligrams/kilogram (mg/kg) ALXN1007 administered IV once weekly for 8 weeks. Participants in Cohort 2 were to receive 20 mg/kg ALXN1007 IV once weekly for 8 weeks. Participants in Cohort 3 were to receive 20 mg/kg ALXN1007 IV twice weekly for 8 weeks. All doses of ALXN1007 were to be administered as a continuous IV infusion. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02241018 -
MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD
|
Phase 2/Phase 3 | |
| Completed |
NCT04539470 -
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1 | |
| Recruiting |
NCT02659657 -
Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation
|
Phase 2 | |
| Completed |
NCT03497273 -
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
|
Phase 1 | |
| Completed |
NCT05825833 -
Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum TNFα Levels in Pediatric HSCT
|
||
| Not yet recruiting |
NCT06294678 -
Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies
|
Phase 3 | |
| Not yet recruiting |
NCT06294691 -
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases
|
Phase 3 | |
| Recruiting |
NCT04285424 -
FMT for Steroid Resistant Gut Acute GVHD
|
Early Phase 1 | |
| Terminated |
NCT01903473 -
Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)
|
Phase 2 | |
| Recruiting |
NCT02044185 -
Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation
|
N/A | |
| Recruiting |
NCT01765634 -
Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease
|
Phase 2 | |
| Terminated |
NCT00282503 -
Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease
|
Phase 3 | |
| Recruiting |
NCT01521039 -
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
|
||
| Terminated |
NCT03721965 -
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT04971551 -
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
|
Phase 2 | |
| Completed |
NCT02743351 -
Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06394895 -
Donor Neutrophil Subsets to Predict the Risk of aGVHD
|
||
| Terminated |
NCT05673876 -
A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)
|
Phase 1 | |
| Recruiting |
NCT02611180 -
Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease
|