Clinical trials: Digestive Disease
Solid Tumors
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsed/refractory solid tumors…
- Trial name
- NCT04774952
- Testing
- RMC-5552
- Where
- 8 sites in United States
- Volunteers
- 58 people
- Sponsor
- Revolution Medicines, Inc.
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Hepatocellular Carcinoma
TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
- Trial name
- NCT05233098
- Testing
- Technetium-99m macroaggregated albumin (Tc-99m MAA)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
Primary Sclerosing Cholangitis
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT04024813
- Testing
- Seladelpar
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1 people
- Sponsor
- Gilead Sciences
Pancreatic Diseases, Bile Duct Diseases
SpyGlass Surgical Study
To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope To identify specific surgical procedures in which intraoperative use of a thin…
- Conditions
- Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease
- Trial name
- NCT05822635
- Testing
- SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
- Where
- 5 sites in United States, China and 2 more
- Volunteers
- 34 people
- Sponsor
- Boston Scientific Corporation
Gastro-Intestinal Disorder
A Pharmacokinetic Comparison of Three Butyrate Products
This study is a randomized, three-arm, interventional study of N=10 apparently healthy men. This study will quantify plasma butyrate responses to a single dose of three different butyrate products.
- Trial name
- NCT06700785
- Testing
- Lysine butyrate, Sodium Butyrate, Tributyrin
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Center for Applied Health Sciences, LLC
Digestive System Disease, Sleepiness
Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
The goal of this interventional study is to investigate effects of a2 Full Cream Milk on Breastmilk composition and subsequent Infant gut health, crying frequency and sleep patterns in Healthy Full-term Infants.
- Conditions
- Digestive System Disease, Sleepiness, Crying
- Trial name
- NCT05829720
- Testing
- a2 Full Cream Milk, Conventional Milk (Weidendorf)
- Where
- 2 sites in China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Crohn Disease
EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to…
- Trial name
- MAINTAIN (NCT05542355)
- Testing
- EXL01, SoC corticosteroid - Induction Period, SoC corticosteroid - Tapering
- Where
- 5 sites in Belgium, Poland
- Volunteers
- 8 people
- Sponsor
- Exeliom Biosciences
Hepatocellular Carcinoma
Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized…
- Trial name
- OPTIMA (NCT02112656)
- Testing
- ThermoDox, Dummy infusion
- Where
- 61 sites in United States, Canada and 12 more
- Volunteers
- 554 people
- Sponsor
- Imunon
Locally Advanced Pancreatic Adenocarcinoma
Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
- Trial name
- NCT03077685
- Testing
- NanoPac®
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- NanOlogy, LLC
Cardiac Disorder, Hepatic Disorder
Kosmos Anatomical Object Labeling and View Identification Pivotal Study
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers.
- Conditions
- Cardiac Disorder, Hepatic Disorder, Spleen Disorder, Kidney Disorder
- Trial name
- NCT06468787
- Testing
- Kosmos Anatomical Object Labeling and View Identification Algorithms
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- EchoNous Inc.
Ileus, Gastro-Intestinal Disorder
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
- Trial name
- INTEGRITY (NCT05470387)
- Testing
- LB1148
- Where
- 23 sites in United States
- Volunteers
- 23 people
- Sponsor
- Palisade Bio
Gastrointestinal Stromal Tumors (GIST), Neoplasms, Connective Tissue
A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
This study will assess the safety, efficacy, and pharmacokinetics of THE-630 in participants with advanced gastrointestinal stromal tumors (GIST).
- Conditions
- Gastrointestinal Stromal Tumors (GIST), Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type
- Trial name
- NCT05160168
- Testing
- THE-630
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Theseus Pharmaceuticals
Hepatitis, Hepatitis C
Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)
This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of grazoprevir (GZR [MK-5172]; 100mg), uprifosbuvir (UPR [MK-3682]; 450 mg) and ruzasvir (RZR [MK-8408]; 60 mg) with and without Ribavirin…
- Conditions
- Hepatitis, Hepatitis C, Digestive System Diseases, Flaviviridae Infections
- Trial name
- NCT02613403
- Testing
- MK-3682B, Ribavirin
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Digestion, Abdominal Pain
Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes
- Conditions
- Digestion, Abdominal Pain, GI Disorders
- Trial name
- NCT06009614
- Testing
- Radicle GI Health Active Study Product 1.1 Usage, Radicle GI Health Active Study Product 2.1 Usage, Radicle GI Health Active Study Product 2.2 Usage
- Where
- United States
- Volunteers
- 2,180 people, healthy volunteers welcome
- Sponsor
- Radicle Science
Nonalcoholic Steatohepatitis, NASH
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients with NASH (Parts B and C).
- Trial name
- NCT04565717
- Testing
- ALN-HSD
- Where
- 13 sites in United States, Belgium and 3 more
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Gastro-Intestinal Disorder
A Study to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of UI059 and UIC202201
A randomized, open-label, multiple-dose crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult…
- Trial name
- NCT06393881
- Testing
- UI059, UIC202201
- Where
- South Korea
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Pancreatic Neoplasm, Digestive System Neoplasm
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination…
- Conditions
- Pancreatic Neoplasm, Digestive System Neoplasm, Neoplasms by Site, Neoplasms
- Trial name
- OSPREY (NCT04493632)
- Where
- 9 sites in Spain, United Kingdom
- Volunteers
- 500 people
- Sponsor
- OncoSil Medical Limited
Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine…
- Trial name
- NCT00838578
- Testing
- KRN330, Irinotecan
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Ulcerative Colitis, Digestive System Diseases
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC)…
- Conditions
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis
- Trial name
- NCT02647866
- Testing
- KHK4083
- Where
- 23 sites in United States, Czechia and 5 more
- Volunteers
- 66 people
- Sponsor
- Kyowa Kirin, Inc.