Clinical trials: Gastrointestinal Infections
Hepatitis B
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.
- Trial name
- NCT00329576
- Testing
- Hepatitis B vaccine
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis C
A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection
- Trial name
- NCT00664625
- Testing
- BMS-791325
- Where
- 6 sites in United States, Argentina
- Volunteers
- 24 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
- Trial name
- NCT00697125
- Testing
- Engerix™-B, HBV-MPL vaccine (208129), Hepatitis B vaccine, experimental formulation
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C Virus Infection
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic…
- Trial name
- NCT02378935
- Testing
- VOX, SOF/VEL, RBV
- Where
- 34 sites in United States, New Zealand and 1 more
- Volunteers
- 205 people
- Sponsor
- Gilead Sciences
Hepatitis B Infection
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
- Trial name
- NCT02304315
- Testing
- GC1102 50,000 IU, GC1102 80,000 IU
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Green Cross Corporation
Tetanus, Poliomyelitis
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4…
- Conditions
- Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
- Trial name
- NCT01248884
- Testing
- Infanrix hexa™, Prevenar 13®, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis C Virus, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve…
- Trial name
- CERTAIN-1 (NCT02707952)
- Testing
- ABT-493/ABT-530, OBV/PTV/r
- Volunteers
- 295 people
- Sponsor
- AbbVie
Diphtheria, Acellular Pertussis
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B…
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b
- Trial name
- NCT00316147
- Testing
- DTPa-HBV-IPV/Hib vaccine
- Where
- 4 sites in India
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects
The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its…
- Trial name
- NCT04309526
- Testing
- NCO-48 Fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nucorion Pharmaceuticals, Inc.
Chronic Hepatitis C
A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
- Trial name
- NCT01511432
- Testing
- telaprevir formulation A, telaprevir Formulation B, telaprevir Formulation C
- Where
- 2 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis B
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®.
- Trial name
- NCT04490499
- Testing
- HBVAXPRO™
- Where
- 10 sites in Finland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg…
- Trial name
- NCT01427868
- Testing
- LB80380 maleate salt, LB80380 free base
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment…
- Trial name
- NCT02431260
- Testing
- INCB054329 Monotherapy
- Where
- 12 sites in United States
- Volunteers
- 69 people
- Sponsor
- Incyte Corporation
Hepatitis C, Chronic
ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632)
This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices.
- Trial name
- ATHENAS (NCT00856024)
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 902 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
- Trial name
- NCT07246889
- Testing
- AHB-137, NA therapy
- Where
- 28 sites in China
- Volunteers
- 577 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects.
- Trial name
- NCT05310487
- Testing
- 162
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Yangshengtang Co., Ltd
Hepatitis C
Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C.
- Trial name
- NCT00686517
- Testing
- Pegylated interferon alfa-2b, Ribavirin
- Volunteers
- 130 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Chronic
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
- Trial name
- OCTOPUS-1 (NCT05275023)
- Testing
- JNJ-73763989, PD-1 inhibitor, Tenofovir Disoproxil
- Where
- 26 sites in Canada, Czechia and 6 more
- Volunteers
- 37 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Hepatitis B
An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
- Trial name
- NCT01264354
- Testing
- Clevudine 30mg, Clevudine 20mg+Adefovir dipivoxil 10mg, Clevudine 20mg
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Bukwang Pharmaceutical
Hepatitis C, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C…
- Trial name
- NCT01853254
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 67 sites in United States, Australia and 9 more
- Volunteers
- 272 people
- Sponsor
- Hoffmann-La Roche
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