Clinical trials: Gastrointestinal Tract
Cystic Fibrosis
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and…
- Trial name
- NCT03119649
- Testing
- GLPG2222 50 mg, GLPG2222 100 mg, GLPG2222 200 mg
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 59 people
- Sponsor
- Lakefront Biotherapeutics NV
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
DX-8951f in Treating Patients With Biliary Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have biliary cancer.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- Trial name
- NCT00005938
- Testing
- exatecan mesylate
- Where
- 5 sites in United States
- Sponsor
- Daiichi Sankyo
PFIC1, PFIC2
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- PEDFIC 1 (NCT03566238)
- Testing
- A4250 (odevixibat)
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 62 people
- Sponsor
- Albireo
Gut, Microbiota Balance
Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being
It is now known that intestinal health has a strong influence on the entire body. Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine.
- Trial name
- PROBAFLOR (NCT06619067)
- Testing
- PROBAFLOR
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Synbiotec Srl
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR)…
- Trial name
- ENVISION (NCT00909727)
- Testing
- Ivacaftor
- Where
- 29 sites in United States, Australia and 5 more
- Volunteers
- 52 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
Solid Tumors, Triple-Negative Breast Cancer
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival.
- Conditions
- Solid Tumors, Triple-Negative Breast Cancer, Non Small Cell Lung Cancer, Renal Cell Carcinoma
- Trial name
- NCT02071862
- Testing
- CB-839, Pac-CB, CBE
- Where
- 13 sites in United States
- Volunteers
- 210 people
- Sponsor
- Calithera Biosciences, Inc
Breast Cancer
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment.
- Trial name
- NCT06126003
- Testing
- Observation
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BioCorteX Inc
Alpha 1-Antitrypsin Deficiency
Safety Dose Finding Study of ADVM-043 Gene Therapy to Treat Alpha-1 Antitrypsin (A1AT) Deficiency
The ADVANCE study is being conducted by Adverum Biotechnologies, Inc. as an open-label, multicenter, dose-escalation study in order to assess the safety and protein expression of ADVM-043 following a single intravenous or…
- Trial name
- ADVANCE (NCT02168686)
- Testing
- ADVM-043
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Adverum Biotechnologies, Inc.
Healthy
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects
This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of…
- Trial name
- NCT04488705
- Testing
- ETD002 - single dose, ETD002 - 7 day repeat dose, ETD002 - 14 day repeat dose
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
Cystic Fibrosis
Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects
The purpose of this study is to assess the pharmacokinetics and safety of VX-809 and VX-770 alone and in combination in healthy subjects.
- Trial name
- NCT01216046
- Testing
- VX-809, VX-770
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Primary Biliary Cholangitis (PBC)
Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)
The goal of this clinical trial is to learn what happens to PVT201 when it enters your body and how it affects your immune system. It will also learn about the safety of PVT201 after a single dose.
- Trial name
- NCT06798454
- Testing
- PVT201
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Parvus Therapeutics, Inc.
Metastatic Cancer, Solid Tumor
LYT-200 Alone and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab in Patients with Metastatic Solid Tumors
- Conditions
- Metastatic Cancer, Solid Tumor, Pancreatic Cancer, Urothelial Carcinoma
- Trial name
- NCT04666688
- Testing
- LYT-200, Tislelizumab, Gemcitabine/nab-paclitaxel
- Where
- 12 sites in United States
- Volunteers
- 44 people
- Sponsor
- PureTech
Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency
ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study
The purpose of this study is to evaluate the efficacy of ARALAST NP A1PI augmentation therapy 120 milligrams per kilogram (mg/kg) body weight (BW)/week compared with an external placebo comparator on the loss of emphysematous…
- Trial name
- NCT04440488
- Testing
- ARALAST NP
- Sponsor
- Shire
Biliary Cancer
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.
- Trial name
- NCT01773785
- Testing
- SPI-1620, Docetaxel
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Diphtheria, Tetanus
Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine
The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00674908
- Testing
- Shan 5, Easy Five
- Where
- 3 sites in India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Advanced Solid Tumors, Colorectal Cancer
Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.
- Conditions
- Advanced Solid Tumors, Colorectal Cancer, Squamous Cell Head and Neck Cancer, Non Small Cell Lung Cancer
- Trial name
- NCT01520389
- Testing
- MM-151, MM-151 + irinotecan
- Where
- 4 sites in United States
- Volunteers
- 112 people
- Sponsor
- Merrimack Pharmaceuticals
Diphtheria, Tetanus
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00343889
- Testing
- DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine, Oral Polio Vaccine
- Where
- 2 sites in Philippines
- Volunteers
- 379 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diabetes Mellitus, Type 2, Metagenome
Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus
A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2, Metagenome, Genetic Predisposition
- Trial name
- NCT04113239
- Testing
- 16S rRNA gene sequencing, DNA-microarray genotyping
- Where
- Russia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Atlas Biomed
Cystic Fibrosis
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes
The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with F/MF genotypes.
- Trial name
- NCT04545515
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 34 sites in Australia, Canada and 8 more
- Volunteers
- 120 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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