Clinical trials: Gastrointestinal Infections
Hepatitis C Virus
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea…
- Trial name
- NCT02951364
- Testing
- LDV/SOF
- Where
- 72 sites in South Korea
- Volunteers
- 1,081 people
- Sponsor
- Gilead Sciences
Hepatitis C
A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2)…
- Trial name
- NCT03253471
- Testing
- AL-611
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Chronic Hepatitis b
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
- Trial name
- NCT04676893
- Testing
- D418 Tab., CKD-388 Tab.
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Hepatitis B, Chronic Hep B
A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B
This study is a multicenter, open-label, phase II clinical study in subjects with chronic hepatitis B (CHB), to characterize the safety, tolerability, pharmacokinetic profile and preliminary anti-hepatitis B virus (HBV) efficacy…
- Conditions
- Hepatitis B, Chronic Hep B, HBV
- Trial name
- NCT04568265
- Testing
- APG-1387, Entecavir 0.5 mg
- Where
- 4 sites in China
- Volunteers
- 122 people
- Sponsor
- Ascentage Pharma Group Inc.
Chronic Hepatitis B
Study to Evaluate Immunogenicity and Safety of TVAX-008 Injection in Non/Treated Chronic Hepatitis B Patients With HBsAg≤20IU/ml or HBsAg Negative Without Serological Conversion
The objective of this study is to assess the immunogenicity and safety of TVAX-008 injection in antiviral untreated/untreated chronic hepatitis B patients with HBsAg≤20 IU/mL, or HBsAg negative and no seroconversion through an…
- Trial name
- NCT07204236
- Testing
- TVAX-008
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.
Hepatitis B
Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children
This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.
- Trial name
- NCT01138098
- Testing
- Engerix™-B
- Where
- 11 sites in Slovakia
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old.
- Trial name
- NCT00511095
- Testing
- HEPLISAV
- Where
- 7 sites in United States
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with…
- Trial name
- NCT05010577
- Testing
- BX004-A
- Where
- 28 sites in United States, Czechia and 3 more
- Volunteers
- 43 people
- Sponsor
- BiomX, Inc.
Chronic Hepatitis b
To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
This trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy.
- Trial name
- NCT05760781
- Testing
- STSG-0002 Injection
- Where
- 4 sites in China
- Volunteers
- 9 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Hepatitis C Virus
TMC435-TiDP16-C112 - Interaction Trial With Antidepressants
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa.
- Trial name
- NCT01090700
- Testing
- TMC435, Escitalopram, TMC435 + Escitalopram
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis B, Hepatitis C
Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment…
- Trial name
- NCT01772121
- Where
- 19 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Gilead Sciences
MRSA, Cystic Fibrosis
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).
- Trial name
- NCT03181932
- Testing
- Vancomycin inhalation powder
- Where
- 71 sites in United States, Canada
- Volunteers
- 188 people
- Sponsor
- Savara Inc.
Hepatitis C Infection
Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)
This is a 3-part study of Ruzasvir (MK-8408) for participants with hepatitis C infection. Successive participants will be enrolled as dose levels are evaluated to find the maximum safe and well tolerated dose of Ruzasvir.
- Trial name
- NCT02076100
- Testing
- Ruzasvir
- Volunteers
- 22 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
This non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy.
- Trial name
- NCT02068963
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 352 people
- Sponsor
- Hologic, Inc.
Chronic Hepatitis B
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are…
- Trial name
- NCT05414981
- Testing
- ABI-H3733
- Where
- 9 sites in Bulgaria, Hong Kong and 4 more
- Volunteers
- 31 people
- Sponsor
- Assembly Biosciences
Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1…
- Trial name
- ELIXIR (NCT02248922)
- Testing
- TIS or TIP
- Where
- 6 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C Infection
Study of a New MVA Vaccine for Hepatitis C Virus
The study is aimed at assessing the safety of AdCh3NSmut and the new candidate vaccine MVA-NSmut when administered sequentially, or alone, to healthy volunteers and patients with hepatitis C virus infection The study also aims at…
- Trial name
- NCT01296451
- Testing
- MVA-NSmut, AdCh3NSmut, AdCh3NSmut1
- Where
- 3 sites in United Kingdom
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- ReiThera Srl
Hepatitis B, Chronic
Drug Drug Interaction Study for EYP001 With Entecavir
This is a Phase 1, single-center, open-label, three subsequent dosing periods study to evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD), safety, and tolerability of a single dose of…
- Trial name
- NCT03469583
- Testing
- EYP001, Entecavir 1 MG
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Enyo Pharma
Chronic Hepatitis, Hepatitis B
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.
- Trial name
- QUASH 1 (NCT00496002)
- Testing
- Clevudine, Adefovir
- Where
- 134 sites in United States, Argentina and 10 more
- Sponsor
- Pharmasset
Chronic Hepatitis B
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
- Trial name
- NCT01760122
- Testing
- Ypeginterferon alfa-2b, Pegasys
- Where
- 43 sites in China
- Volunteers
- 820 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
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