Clinical trials: Acute Gastrointestinal Graft-versus-host Disease
Hepatitis C
DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)
The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting…
- Trial name
- DARE-C II (NCT02156570)
- Testing
- Sofosbuvir and ribavirin
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 20 people
- Sponsor
- Kirby Institute
Safety and Efficacy
Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement
Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation.
- Trial name
- NCT06066840
- Testing
- Basiliximab, Vedolizumab
- Where
- China
- Volunteers
- 45 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Graft vs Host Disease
Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for various hematologic diseases. However, one of the major challenges of allo-HSCT is the occurrence of graft-versus-host disease (GvHD)…
- Trial name
- NCT07364617
- Testing
- Fecal microbiota transplantation (FMT)
- Where
- Taiwan
- Volunteers
- 35 people
- Sponsor
- Chang Gung Memorial Hospital
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD)
Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids.
- Trial name
- NCT04059757
- Testing
- Fecal Microbiota Transplantation (FMT)
- Where
- United States
- Sponsor
- Leland Metheny
Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD
MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients
MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as…
- Trial name
- ARES (NCT04769895)
- Testing
- MaaT013
- Where
- 50 sites in Austria, Belgium and 4 more
- Volunteers
- 66 people
- Sponsor
- MaaT Pharma
Haematopoietic Stem Cell Transplantation
Endomicroscopy and Graft-versus-host Disease
Early diagnosis of acute Gastrointestinal Graft-versus-Host disease (aGI-GvHD) has a strong impact on morbidity and mortality of patients who underwent haematopoietic stem cell transplantation (HSCT).
- Trial name
- NCT01583712
- Testing
- Confocal laser endomicroscopy, Confocal Laser Endomicroscope
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Vienna
Hematopoietic and Lymphoid Cell Neoplasm
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD).
- Trial name
- FEMITGIGVHD (NCT03812705)
- Testing
- fecal microbiome transplantation
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Graft Versus Host Disease in GI Tract
Fecal Microbiota Transplantation in aGvHD After ASCT
Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT).
- Trial name
- NCT03819803
- Testing
- Fecal microbiota transplantation
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- Medical University of Graz
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
Endocytoscopy
Endocytoscopy of Upper Gastrointestinal Tract in Acute Graft-versus-host Disease: a Pilot Study
The goal of this clinical trial is to test the assess the diagnostic effectiveness of endocytoscopy in patients with underlying UGI aGvHD. The main question it aims to answer is: the effectiveness of ECS for diagnosing UGI aGvHD.
- Trial name
- NCT06247891
- Testing
- ECS Group
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Ruijin Hospital
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
Cholecystitis, Cholecystitis, Acute
M-Tapa Block for Laparoscopic Cholesistectomy
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is…
- Conditions
- Cholecystitis, Cholecystitis, Acute, Cholecystitis, Chronic
- Trial name
- NCT05179629
- Testing
- M TAPA block
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Medipol University
Graft-versus-host Disease Prevention
Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics
This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibiotics.
- Trial name
- NCT03862079
- Testing
- Best Practice, Fecal Microbiota Transplantation, Nystatin
- Where
- United States
- Sponsor
- M.D. Anderson Cancer Center
Fecal Microbiota Transplantation
Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality.
- Trial name
- HERACLES (NCT03359980)
- Testing
- fecal microbiota transfer
- Where
- 16 sites in France, Italy and 1 more
- Volunteers
- 24 people
- Sponsor
- MaaT Pharma
Acute Graft Versus Host Disease, Intestinal Graft Versus Host Disease
Methylprednisolone Sodium Succinate in Treating Patients With Acute Graft-versus-Host Disease of the Gastrointestinal Tract
This phase II trial studies how well methylprednisolone sodium succinate works in treating patients with graft-versus-host disease (GVHD) of the gastrointestinal tract that has begun within 100 days of transplant (acute GVHD).
- Trial name
- NCT02425813
- Testing
- Budesonide, Methylprednisolone Sodium Succinate
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
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
Acute Gastrointestinal Graft-versus-host Disease
Prospective Randomized Controlled Study: Amimaitosai Injection Combined With Corticosteroids for Gastrointestinal aGVHD
This study focuses on patients with gastrointestinal-dominant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.
- Trial name
- NCT07803978
- Testing
- Amimaitosai injection, Methylprednisolone
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Chinese PLA General Hospital
Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation. This Program is available for female and male who are recipients of allogenic HSCT and who have been newly…
- Conditions
- Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease, Graft-versus-host-disease, Graft Vs Host Disease
- Trial name
- NCT03172455
- Testing
- Glassia
- Sponsor
- Impatients N.V. trading as myTomorrows
Cholecystitis, Acute, Cholecystitis, Chronic
BDD With UDCA Therapy After Laparoscopic Cholecystectomy
Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy Primary endpoint: peak level of postoperative AST…
- Trial name
- BULQ-LC (NCT03578055)
- Testing
- BDD with UDCA
- Where
- South Korea
- Volunteers
- 172 people
- Sponsor
- Ewha Womans University Mokdong Hospital
Hematologic Malignancies
Efficacy Study of a TXA127 to Reduce Acute Graft-vs-Host Disease in Subjects Undergoing Double Umbilical Cord Blood Transplantation
The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double umbilical cord blood transplantation (UCBT).
- Trial name
- NCT01882374
- Testing
- TXA127
- Where
- United States
- Sponsor
- Tarix Pharmaceuticals