Clinical trials: Intestinal GVHD
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
Graft Vs Host Disease
Treatment of Gastro-Intestinal and/or Hepatic Graft Versus Host Disease With Budesonide in Patients Following Peripheral Blood Stem Cell Transplantation
Twenty-four (2 x 12) patients with intestinal graft versus host disease (GVHD) Grades 2, 3 or 4 will be treated with budesonide 3mg three times daily or placebo for 12 weeks.
- Trial name
- NCT00128739
- Testing
- Budesonide
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- Rafa Laboratories
Malignant Pain, Non-malignant Pain
To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
- Trial name
- NCT02321397
- Testing
- Oxycodone, Naloxone
- Where
- Germany
- Volunteers
- 155 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Allogeneic Hematopoietic Stem Cell Transplantation
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal…
- Trial name
- NCT02993783
- Testing
- Vedolizumab
- Where
- 15 sites in United States, Belgium and 3 more
- Volunteers
- 17 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Hematopoietic Stem Cells
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in…
- Trial name
- NCT03657160
- Testing
- Vedolizumab
- Where
- 139 sites in United States, Argentina and 25 more
- Volunteers
- 343 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Constipation
A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation
Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the…
- Trial name
- NCT02073006
- Testing
- Natural Fibre Supplement
- Where
- Ireland
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Atlantia Food Clinical Trials
Chronic Constipation
Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)
Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with placebo (a sugar pill) for the treatment of chronic constipation.
- Trial name
- NCT00391820
- Testing
- TD-5108
- Where
- United States
- Volunteers
- 360 people
- Sponsor
- Alfasigma S.p.A.
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Healthy, Lupus
Direct to Patient Minimal Risk Biospecimen and Data Collection Research
This study aims to help researchers better understand health conditions and develop improved tests, treatments, and cures for diseases.
- Conditions
- Healthy, Lupus, Celiac, Kidney Disease
- Trial name
- JBMR (NCT07128966)
- Testing
- Observation
- Where
- United States
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- Joined Bio
Intestinal GVHD, Steroid Refractory GVHD
Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013
The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.
- Trial name
- ORION (NCT05017688)
- Testing
- Blood and stool sample collection
- Where
- 9 sites in France
- Volunteers
- 40 people
- Sponsor
- MaaT Pharma
Acute-graft-versus-host Disease
Safety and Tolerability of FMT Capsules in Healthy Volunteers
This is a two-part, randomized, double-blind, placebo-controlled, single center study to investigate the safety and tolerability of XBI-302 administered orally in healthy volunteers.
- Trial name
- NCT05352269
- Testing
- XBI-302
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shenzhen Xbiome Biotech Co., Ltd.
Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD
Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease
MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading…
- Trial name
- ATLAS (NCT04768907)
- Testing
- MaaT013
- Where
- 46 sites in Austria, Belgium and 6 more
- Sponsor
- MaaT Pharma