Clinical trials: Acute Gastrointestinal Graft-versus-host Disease
Acute Graft vs Host Disease
Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD
A Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of F-652 in combination with systemic corticosteroids in subjects who have undergone Hematopoietic Stem Cell Transplantation (HSCT) and have…
- Trial name
- NCT02406651
- Testing
- Recombinant Human Interleukin-22 IgG2-Fc (F-652), Systemic Corticosteroids
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- EVIVE Biotechnology
Graft Versus Host Disease
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI…
- Trial name
- NCT02956122
- Testing
- GLASSIA, methylprednisolone or equivalent steroid, Albumin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Baxalta now part of Shire
Mucositis, Graft-versus-host Disease
Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180.
- Trial name
- NCT00360685
- Testing
- Tac+MTX, TAC + MMF
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
GVHD
Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.
- Trial name
- NCT05415410
- Testing
- Apraglutide
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 31 people
- Sponsor
- VectivBio AG
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant
RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- GVHD (NCT00408681)
- Testing
- lithium carbonate, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Fred Hutchinson Cancer Center
Acute Gastrointestinal Graft vs Host Disease
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
- Trial name
- SUPPORTS (NCT00926575)
- Testing
- oral beclomethasone 17,21-dipropionate
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- Soligenix
Graft Versus Host Disease
Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug Natalizumab in treating Acute Graft-Versus-Host Disease (GVHD) in the Gastrointestinal (GI) Tract.
- Trial name
- NCT02176031
- Testing
- Natalizumab, Methylprednisolone
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Dana-Farber Cancer Institute
Acute Graft-Versus-Host Disease, GIGVHD
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
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…
- Trial name
- GIGVHD (NCT02245412)
- Testing
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly, ALXN1007 20 mg/kg twice weekly
- Where
- 12 sites in United States, France
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.