Clinical trials: Gastrointestinal Infection
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
Hepatitis C, HCV
TD-6450 MAD Study in HCV Infected Subjects
This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.
- Trial name
- NCT02116543
- Testing
- TD-6450
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Theravance Biopharma
Shigellosis
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain…
- Trial name
- S4V03 (NCT06615375)
- Testing
- Shigella4V2
- Where
- 3 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Chronic Hepatitis b
An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b
This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility.
- Trial name
- NCT04157699
- Testing
- TDF tablet, QL-007
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Chronic Hepatitis C
Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in…
- Trial name
- NCT01581398
- Testing
- Ypeginterferon alfa-2b, Pegasys
- Where
- 42 sites in China
- Volunteers
- 770 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatitis B
Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection
The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous injection.
- Trial name
- NCT01606163
- Testing
- GC1102, JW normal saline
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Hepatitis C Virus Infection
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric…
- Trial name
- NCT03820258
- Testing
- SOF/VEL/VOX
- Where
- 10 sites in Italy, Poland and 1 more
- Volunteers
- 21 people
- Sponsor
- Gilead Sciences
Hepatitis B, Diphtheria
Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
- Conditions
- Hepatitis B, Diphtheria, Whole Cell Pertussis, Tetanus
- Trial name
- NCT00317187
- Testing
- Tritanrix-HepB/Meningitec conjugate vaccine, Tritanrix/Hiberix vaccine
- Where
- Thailand
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at…
- Trial name
- NCT00698087
- Testing
- MPL-Adjuvanted recombinant hepatitis B vaccine, Engerix™-B
- Where
- Austria
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C
Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule…
- Trial name
- NCT01181804
- Testing
- boceprevir
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis A
Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by…
- Trial name
- NCT06058416
- Testing
- Healive (hepatitis A vacine(human diploid cell), inactivated)
- Where
- China
- Volunteers
- 1,092 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Chronic Hepatitis B
Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing.
- Trial name
- NCT00277576
- Testing
- ppdpSC18 administered by PMED
- Where
- 9 sites in Hong Kong, Singapore and 2 more
- Volunteers
- 48 people
- Sponsor
- PowderMed
Chronic Hepatitis B
Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.
- Trial name
- NCT00513968
- Testing
- a mixed plasmid DNA (HB-110), Adefovir
- Where
- South Korea
- Volunteers
- 27 people
- Sponsor
- Genexine, 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
Hepatitis B, Infectious Disease
A Study in Healthy Volunteers
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers.
- Conditions
- Hepatitis B, Infectious Disease, Liver Diseases
- Trial name
- NCT03596697
- Testing
- CRV431, TDF
- Where
- 3 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis
Hepatitis C
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants.
- Trial name
- NCT00998985
- Testing
- Grazoprevir
- Volunteers
- 91 people
- Sponsor
- Merck Sharp & Dohme LLC
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
HCV Infection
Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection
This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in adults with chronic Hepatitis C Virus (HCV).
- Trial name
- NCT00874796
- Testing
- GS-9450
- Where
- 73 sites in United States, Canada and 4 more
- Volunteers
- 307 people
- Sponsor
- Gilead Sciences
Hepatitis b & Liver Dysfunction
Study on PK of Hydronidone in Patients and Special Population
1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction). 2.
- Trial name
- NCT04123769
- Testing
- Hydronidone
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
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