Clinical trials: Gastrointestinal Tract
Cystic Fibrosis
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and…
- Trial name
- NCT02951195
- Testing
- VX-152, TEZ/IVA, IVA
- Where
- 16 sites in United States
- Volunteers
- 80 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Solid Tumor, Non-small Cell Lung Cancer
A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors.
- Conditions
- Solid Tumor, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Colorectal Cancer
- Trial name
- NCT07623369
- Testing
- HH160
- Where
- 3 sites in Australia, China
- Volunteers
- 299 people
- Sponsor
- Huahui Health
Solid Tumor Cancer, Locally Advanced
AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a…
- Conditions
- Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers
- Trial name
- NCT07038343
- Testing
- AVZO-1418, Combination Agent 1, Combination Agent 2
- Where
- 27 sites in United States, China
- Volunteers
- 480 people
- Sponsor
- Avenzo Therapeutics, Inc.
Cystic Fibrosis
Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF)…
- Trial name
- NCT03633526
- Testing
- VX-659/TEZ/IVA, IVA
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
- Trial name
- NCT00434278
- Testing
- Dornase alfa
- Where
- 40 sites in United States
- Volunteers
- 27 people
- Sponsor
- Genentech, Inc.
Cystic Fibrosis
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection.
- Trial name
- KB001-A (NCT01695343)
- Testing
- KB001-A
- Where
- 67 sites in United States, Australia and 2 more
- Volunteers
- 182 people
- Sponsor
- Humanigen, Inc.
Hepatocellular Carcinoma, Biliary Tract Cancer
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
- Trial name
- NCT05775159
- Testing
- Volrustomig, Bevacizumab, Lenvatinib
- Where
- 46 sites in United States, China and 7 more
- Volunteers
- 294 people
- Sponsor
- AstraZeneca
Advanced Solid Tumor, Colorectal Cancer
A Study of KF-0210 in Advanced Solid Tumors Patients
The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Colorectal Cancer, Lung Cancer, Squamous Cell Carcinoma of the Esophagus
- Trial name
- NCT04713891
- Testing
- KF-0210 tablets, 120 mg, KF-0210 tablets, 240 mg, KF-0210 tablets, 450 mg
- Where
- Australia
- Volunteers
- 14 people
- Sponsor
- Keythera Pharmaceuticals (Australia) Pty Ltd
Biliary Tract Neoplasms
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants…
- Trial name
- KN035-BTC (NCT03478488)
- Testing
- KN035 plus Gemcitabine & oxaliplatin, Gemcitabine & oxaliplatin
- Where
- China
- Volunteers
- 472 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Sleep Apnea, Hypertension
Tri Staple Technology Stapler Used in Gastric Bypass
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
- Conditions
- Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease
- Trial name
- NCT01026103
- Testing
- Tri Staple Technology stapler
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Cystic Fibrosis, Mucociliary Clearance
A Phase 1 Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS 9411 in Subjects With Cystic Fibrosis (CF)
The purpose of this study is to evaluate the safety and tolerability of GS-9411 in patients with Cystic Fibrosis. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.
- Trial name
- NCT01025713
- Testing
- GS-9411
- Where
- Australia
- Sponsor
- Gilead Sciences
Infant Gut Microbiome
The EFFECT Study: Probiotic and HMO Supplementation in Infants
Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial…
- Trial name
- EFFECT (NCT03994315)
- Testing
- B. infantis EVC001, Lacto-N-tetraose (LNT)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Evolve BioSystems, Inc.
Colorectal Cancer, Gastric Adenocarcinoma
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor [CAR] T), in adult participants with…
- Conditions
- Colorectal Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Adenocarcinoma
- Trial name
- NCT07544589
- Testing
- DISP-10
- Where
- 7 sites in United States
- Volunteers
- 66 people
- Sponsor
- Dispatch Biotherapeutics
Primary Sclerosing Cholangitis
Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT05642468
- Testing
- Ritivixibat
- Where
- 8 sites in France, Italy and 2 more
- Volunteers
- 18 people
- Sponsor
- Albireo, an Ipsen Company
Upper Respiratory Tract Infections, Rhinopharyngitis
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of…
- Conditions
- Upper Respiratory Tract Infections, Rhinopharyngitis, Sore Throat, Sinusitis
- Trial name
- NCT01315418
- Testing
- 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®), 2-Non fermented dairy product (control)
- Where
- France
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Alagille Syndrome
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives.
- Trial name
- NCT06850038
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
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
Primary Biliary Cholangitis
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Trial name
- NCT03092765
- Testing
- E6011
- Where
- 46 sites in Japan
- Volunteers
- 29 people
- Sponsor
- EA Pharma Co., Ltd.
Cystic Fibrosis
A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation
The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual…
- Trial name
- NCT05076149
- Testing
- VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA
- Where
- 170 sites in United States, Australia and 18 more
- Volunteers
- 597 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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