Clinical trials: Gastrointestinal and Digestive Disorder
Hepatitis E, Hepatitis B
A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(Coadministration With Recombinant Hepatitis B Vaccine)
This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine.
- Trial name
- NCT02584543
- Testing
- HEV vaccine, HBV vaccine
- Where
- China
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Dysphagia
Acceptability and Tolerance Study of a Thickener
This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia
- Trial name
- NCT05026476
- Testing
- Resource Thicken up Junior
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- Société des Produits Nestlé (SPN)
Gastric Adenocarcinoma
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e.
- Trial name
- FIDES-03 (NCT04604132)
- Testing
- Derazantinib, Derazantinib-paclitaxel-ramucirumab combination
- Where
- 81 sites in United States, Argentina and 13 more
- Volunteers
- 47 people
- Sponsor
- Basilea Pharmaceutica
Colorectal Neoplasms, Neoplasm Metastasis
Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.
- Trial name
- AFFIRM (NCT00851084)
- Testing
- aflibercept, oxaliplatin, 5-FU
- Where
- 37 sites in Australia, Germany and 5 more
- Volunteers
- 268 people
- Sponsor
- Sanofi
Ulcerative Colitis
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT04706793
- Testing
- Etrasimod
- Where
- 38 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma
Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
- Trial name
- NCT04187352
- Testing
- CS1001+ Fluorouracil+Cisplatin
- Where
- 72 sites in China
- Volunteers
- 540 people
- Sponsor
- CStone Pharmaceuticals
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Children With GERD
The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.
- Trial name
- NCT00141817
- Testing
- pantoprazole for approximately 9 weeks.
- Where
- 23 sites in United States
- Volunteers
- 41 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Chronic Hepatitis B
Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to…
- Trial name
- LB80380 (NCT01242787)
- Testing
- LB80380, Entecavir 0.5 mg
- Where
- 2 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
Colorectal Cancer
PETACC-8 miR-31-3p and miR-31-5p Ancillary Study
This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer.
- Trial name
- NCT03362684
- Testing
- Cetuximab, FOLFOX
- Volunteers
- 1,808 people
- Sponsor
- IntegraGen SA
Coeliac Disease, Celiac Disease
Safety Study of Nexvax2 in Subjects With Coeliac Disease
The main purpose of this study is to determine the safety of weekly injections of Nexvax2 given for three weeks to patients with coeliac disease who have been on a gluten-free diet.
- Trial name
- NCT00879749
- Testing
- 9 micrograms Nexvax2, 30 micrograms Nexvax2, 90 micrograms Nexvax2
- Where
- 2 sites in Australia
- Volunteers
- 34 people
- Sponsor
- Nexpep Pty Ltd
NASH - Nonalcoholic Steatohepatitis, NAFLD
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, T2DM (Type 2 Diabetes Mellitus)
- Trial name
- NCT03291249
- Testing
- Foralumab, Omeprazole 20mg
- Sponsor
- Tiziana Life Sciences LTD
Hepatocellular Carcinoma
Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Participants With Hepatocellular Carcinoma
The purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo.
- Trial name
- NCT05564338
- Testing
- Sitravatinib, Tislelizumab
- Sponsor
- BeiGene
Alpha 1-Antitrypsin Deficiency
A Study of Belcesiran in Patients With AATLD
This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD).
- Trial name
- ESTRELLA (NCT04764448)
- Testing
- Belcesiran
- Where
- 23 sites in United States, Australia and 12 more
- Volunteers
- 16 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Lung Disease, Pulmonary Disease
NTLA-3001 in Adults with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease
This study will be conducted to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of NTLA-3001 in adults with alpha-1 antitrypsin deficiency (AATD) -associated lung disease
- Conditions
- Lung Disease, Pulmonary Disease, AATD, Alpha-1 Antitrypsin Deficiency
- Trial name
- AATD (NCT06622668)
- Testing
- Biological NTLA-3001
- Where
- New Zealand
- Sponsor
- Intellia Therapeutics
Short Bowel Syndrome
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal…
- Trial name
- NCT04775706
- Testing
- HM15912 Active
- Where
- 15 sites in United States, Belgium and 6 more
- Volunteers
- 18 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Alopecia Areata, Depressive Episode
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and…
- Conditions
- Alopecia Areata, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders
- Trial name
- NCT04239521
- Testing
- Exposure of interest (studies 2 & 3).
- Where
- United Kingdom
- Volunteers
- 51,955 people
- Sponsor
- Momentum Data
Chronic Atrophic Gastritis, Hypergastrinemia
YF476 and Type I Gastric Carcinoids (Norway)
The aim of the study is to find out if the experimental medicine, YF476, can make gastric carcinoids, a rare type of stomach tumour, shrink and disappear.
- Conditions
- Chronic Atrophic Gastritis, Hypergastrinemia, Type I Gastric Carcinoids
- Trial name
- NCT01444014
- Testing
- YF476
- Where
- Norway
- Volunteers
- 8 people
- Sponsor
- Trio Medicines Ltd.
Colorectal Cancer (CRC), Advanced Adenomas (AA)
Collection of Samples USOPTIVAL Study
A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC…
- Trial name
- NCT04792684
- Testing
- Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
- Where
- 16 sites in United States
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- Universal Diagnostics
Urinary Tract Infections, Infectious Diarrhea
Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
The purpose of this study is to assess the feasibility of TrueLoo™, an Internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across…
- Conditions
- Urinary Tract Infections, Infectious Diarrhea, Clostridium Difficile Infection, Gastrointestinal Disease
- Trial name
- NCT05008640
- Testing
- TrueLoo™
- Where
- 6 sites in United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Toi Labs, Inc.
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus…
- Trial name
- NCT02413593
- Testing
- LDV/SOF, RBV
- Where
- 15 sites in Canada
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences
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