Clinical trials: Digestive Tract Diseases
Alpha1-antitrypsin Deficiency
GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
The purpose of the study is 2-fold: (1) to evaluate the safety and potential immunogenicity of GLASSIA following intravenous (IV) administration via in-line filtration; and (2) to assess the effects of GLASSIA augmentation…
- Trial name
- NCT02525861
- Testing
- GLASSIA
- Where
- 18 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Baxalta now part of Shire
Advanced Malignancies, Metastatic Cancer
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
- Trial name
- NCT03126110
- Testing
- INCAGN01876, Nivolumab, Ipilimumab
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 145 people
- Sponsor
- Incyte Biosciences International Sàrl
Microbiome, Metabolic Syndrome
Dietary Fibers Effect on the Gut Microbiota Composition
The randomized double-blinded placebo-controlled multicenter study will be held in parallel groups. During 5 weeks the efficacy of different endpoints as a measure of response to the daily intake of dietary fibers (8 g of either…
- Conditions
- Microbiome, Metabolic Syndrome, Cardiovascular Risk Factor, Inflammation
- Trial name
- NCT04114513
- Testing
- Maltodextrin, Inulin, Pectin
- Where
- Russia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Atlas Biomed
Gastric Cancer, Triple Negative Breast Cancer
A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment
This is a a Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination with MGD013 in Patients with Advanced or…
- Conditions
- Gastric Cancer, Triple Negative Breast Cancer, Biliary Tract Carcinoma, Endometrial Carcinoma
- Trial name
- NCT04178460
- Testing
- Niraparib combined with MGD013
- Where
- 19 sites in China
- Volunteers
- 60 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT07293897
- Testing
- Maralixibat
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Takeda
Gallbladder Disease, Biliary Colic
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic…
- Conditions
- Gallbladder Disease, Biliary Colic, Gallstones
- Trial name
- NCT01410734
- Testing
- Indocyanine green (ICG)
- Where
- 2 sites in Italy, Switzerland
- Volunteers
- 72 people
- Sponsor
- Intuitive Surgical
Primary Sclerosing Cholangitis
A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
- Trial name
- NCT02704364
- Testing
- NGM282
- Where
- 38 sites in United States, France and 2 more
- Volunteers
- 62 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Alpha1-Antitrypsin Deficiency
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC…
- Trial name
- NCT04722887
- Testing
- Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human)
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Grifols Therapeutics LLC
Advanced Solid Tumors, Biliary Tract Cancer
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid…
- Trial name
- NCT03440450
- Testing
- FF-10832 Gemcitabine Liposome Injection
- Where
- 7 sites in United States
- Volunteers
- 90 people
- Sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
Gastrointestinal Stromal Tumors, Small-cell Lung Cancer
A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit
This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and/or metastatic solid tumors known to express c-Kit.
- Conditions
- Gastrointestinal Stromal Tumors, Small-cell Lung Cancer, Adenoid Cystic Carcinoma, Uveal Melanoma
- Trial name
- NCT06805825
- Testing
- NN3201
- Where
- 5 sites in United States
- Volunteers
- 67 people
- Sponsor
- Novelty Nobility, Inc.
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
Healthy Volunteers, Pancreatic Ductal Adenocarcinoma
Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors
This is a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors
- Conditions
- Healthy Volunteers, Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Esophageal Squamous Cell Carcinoma
- Trial name
- RAD301 (NCT05799274)
- Testing
- RAD301 ([68Ga]-RAD301)
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Radiopharm Theranostics, Ltd
Pancreatic Cancer, Breast Cancer
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
- Conditions
- Pancreatic Cancer, Breast Cancer, Gastric Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT05215574
- Testing
- NGM831, NGM831 plus pembrolizumab (KEYTRUDA®), NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
- Where
- 9 sites in United States
- Volunteers
- 130 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Cystic Fibrosis
A Multi-Center Study of the CF Quantum® Sweat Test System
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System.
- Trial name
- NCT02404714
- Testing
- Iontophoresis sweat test
- Where
- 6 sites in United States
- Volunteers
- 55 people
- Sponsor
- Polychrome Medical, Inc.
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT01949870
- Testing
- Cisplatin, Gemcitabine, Selumetinib
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Cancer, Lung, Perfusion Computed Tomography Target Lesion
DCE-CT of Thoracic Tumors as an Early Biomarker for Treatment Monitoring in Comparison With Morphologic Criteria
DCE-CT of thoracic tumors as an early biomarker for treatment monitoring in comparison with morphologic criteria. 1. Rationale of the clinical investigation For the evaluation of response to anti-tumoral therapy in thoracic…
- Conditions
- Cancer, Lung, Perfusion Computed Tomography Target Lesion, Cancer Liver, Metastatic Lung Cancer
- Trial name
- NCT04708483
- Testing
- Extra DCE-CT scan
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Hyperfusion
Hepatocellular Carcinoma, Non-small Cell Lung Cancer
Phase I/II Study of Anti-Mucin1 (MUC1) CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor
The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for patients with relapsed or refractory solid tumor.
- Conditions
- Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Pancreatic Carcinoma, Triple-Negative Invasive Breast Carcinoma
- Trial name
- NCT02587689
- Testing
- anti-MUC1 CAR T Cells
- Where
- China
- Volunteers
- 20 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Colorectal Neoplasm, Head and Neck Neoplasm
Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker.
- Conditions
- Colorectal Neoplasm, Head and Neck Neoplasm, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasm
- Trial name
- NCT00423150
- Testing
- Temozolomide
- Volunteers
- 86 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-small Cell Lung Cancer, Breast Cancer
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma
- Trial name
- NCT04440943
- Testing
- CDX-527
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celldex Therapeutics
Obesity
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones
The study is designed to assess whether repeated dosing with CE-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic.
- Trial name
- NCT00576589
- Testing
- CE-326,597
- Where
- 12 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
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