Clinical trials: Digestive System
Hepatitis B
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
- Trial name
- NCT00412750
- Testing
- Telbivudine (LdT), peginterferon alpha-2a
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Novartis
Hepatitis C, Chronic, Healthy Volunteer
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1.
- Trial name
- NCT01181024
- Testing
- RO5303253
- Where
- New Zealand
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Gastric Cancer, Cancer of the Stomach
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic…
- Conditions
- Gastric Cancer, Cancer of the Stomach, Esophagogastric Junction
- Trial name
- NCT03662659
- Testing
- BMS-986213, Nivolumab, XELOX
- Where
- 79 sites in United States, Argentina and 15 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Helicobacter Pylori Associated Gastrointestinal Disease
Drug-drug Interactions and Safety Among JP-1366, Amoxicillin, and Clarithromycin in Healthy Volunteers
To evaluate the effect of coadministration of amoxicillin and clarithromycin on safety, tolerability and pharmacokinetics of JP-1366 in healthy subjects and the effect of JP-1366 on safety, tolerability and pharmacokinetics of…
- Trial name
- NCT05194046
- Testing
- JP-1366 20mg 1capsule, Amoxicillin 500Mg Cap, Clarithromycin 500Mg Tab
- Where
- South Korea
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Onconic Therapeutics Inc.
Ulcerative Colitis
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.
- Trial name
- NCT05061446
- Testing
- Etrasimod
- Where
- 80 sites in Japan
- Volunteers
- 54 people
- Sponsor
- Pfizer
Hepatitis A, Hep A
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2…
- Trial name
- NCT05613127
- Testing
- Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL, HAVRIX 720 Junior 0.5 mL
- Where
- 2 sites in South Korea, Thailand
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.
Colorectal Cancer
A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.
- Trial name
- NCT01032291
- Testing
- cetuximab, lenalidomide
- Where
- 17 sites in Australia, Belgium and 4 more
- Volunteers
- 51 people
- Sponsor
- Celgene Corporation
Hepatitis C
Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)
This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon.
- Trial name
- NCT03537274
- Testing
- PEG-Intron, Interferon Alfa-2B
- Volunteers
- 1,224 people
- Sponsor
- Merck Sharp & Dohme LLC
Reflux Oesophagitis
Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers
The objective of the study was to assess whether the tolerance to the effect of YF476 on gastric pH observed with repeated doses in a previous study in healthy volunteers can be avoided by using smaller doses of YF476.
- Trial name
- NCT01597674
- Testing
- YF476
- Where
- United Kingdom
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Trio Medicines Ltd.
Crohn's Disease
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
- Trial name
- NCT02531113
- Testing
- RPC1063
- Where
- 28 sites in United States, Canada and 3 more
- Volunteers
- 69 people
- Sponsor
- Celgene
Ulcerative Colitis
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.
- Trial name
- NCT03800420
- Where
- 11 sites in United States
- Volunteers
- 16 people
- Sponsor
- Bridge Biotherapeutics, Inc.
Colorectal Cancer
ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
This is a Phase 1b open-label, multiple dose/schedule sequential study to determine the safety and efficacy of the oxidative phosphorylation (OxPhos) pathway inhibitor ME-344 in combination with bevacizumab in subjects with…
- Trial name
- NCT05824559
- Testing
- ME-344, Bevacizumab
- Where
- 7 sites in United States
- Volunteers
- 23 people
- Sponsor
- MEI Pharma, Inc.
Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
- Conditions
- Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms
- Trial name
- NCT02834780
- Testing
- H3B-6527
- Where
- 44 sites in United States, Belgium and 9 more
- Volunteers
- 128 people
- Sponsor
- H3 Biomedicine Inc.
Colorectal Cancer
Specimens for Septin 9 Performance
Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker…
- Trial name
- SPR0012 (NCT01329718)
- Testing
- Blood Sample
- Volunteers
- 562 people, healthy volunteers welcome
- Sponsor
- Epigenomics, Inc
Ulcerative Colitis
(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis.
- Trial name
- NCT00679380
- Testing
- Blood sampling, endoscopy, Budesonide MMX® 6 mg, Budesonide MMX® 9 mg
- Where
- 71 sites in Australia, Belgium and 13 more
- Volunteers
- 514 people
- Sponsor
- Bausch Health Americas, Inc.
Gastrointestinal Stromal Tumors
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent…
- Trial name
- NCT04282980
- Testing
- DCC-2618
- Where
- 9 sites in China
- Volunteers
- 39 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Drug Interaction Potential
Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
This study has two parts. Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents.
- Trial name
- NCT03291288
- Testing
- Tolbutamide, Midazolam, Pexidartinib
- Where
- 11 sites in United States, Netherlands and 2 more
- Volunteers
- 32 people
- Sponsor
- Daiichi Sankyo
Pancreatic Cancer
XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
This trial will include 2 portions (phase 1 and phase 2). The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT)…
- Trial name
- 1-BETTER (NCT04825288)
- Testing
- Phase I: XB2001 250 mg, Phase I: XB2001 500 mg, Phase I: XB2001 1000 mg
- Where
- 30 sites in United States
- Volunteers
- 76 people
- Sponsor
- XBiotech, Inc.
Colorectal Cancer
A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer
This study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced…
- Trial name
- NCT07474727
- Testing
- AMT-676, 5-FU, Leucovorin
- Where
- 19 sites in China
- Volunteers
- 180 people
- Sponsor
- Multitude Therapeutics Inc.
Non-alcoholic Fatty Liver Disease
Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome
The study is designed to assess the safety and efficacy of different doses and dosing regimens of Runihol, tablets, enteric coated, produced by "NTFF" POLYSAN" (Russia), in prevention of liver disease progression in patients with…
- Trial name
- NCT02930161
- Testing
- Runihol
- Where
- 3 sites in Russia
- Volunteers
- 35 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
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