Clinical trials: Gastrointestinal Infection
Chronic Hepatitis C
Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects
- Trial name
- NCT04232514
- Testing
- HEC74647, HEC110114
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatitis C Virus Infection
A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382
The purpose of this study is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up to the maximum tolerated…
- Trial name
- NCT01482611
- Testing
- JNJ-47910382
- Where
- Germany
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Hepatitis B
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
- Trial name
- NCT02604212
- Testing
- ARC-520, entecavir, antihistamine
- Where
- 16 sites in China, Germany and 1 more
- Volunteers
- 32 people
- Sponsor
- Arrowhead Pharmaceuticals
Healthy
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
- Trial name
- NCT01005407
- Testing
- Engerix-B
- Where
- 32 sites in United States, Canada
- Volunteers
- 2,452 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Virus Diseases, Hepatitis B
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
- Trial name
- NCT02012998
- Testing
- HBVAXPRO 5µg
- Where
- 10 sites in Italy
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Healthy
A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a
A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.
- Trial name
- GlycoShig3 (NCT04602975)
- Testing
- Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg, Injection SF2A-TT15 2 µg Adjuvanted
- Where
- Kenya
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Hepatitis B
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered…
- Trial name
- NCT00697216
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Where
- 2 sites in Belgium, Denmark
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B Virus Associated Liver Disease
Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation.
- Trial name
- NCT01421212
- Testing
- Hepatitis B Immune Globulin (Boca HBVIg)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biotest Pharmaceuticals Corporation
Hepatitis C, Chronic, Hepacivirus
Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)
The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness.
- Trial name
- NCT00705263
- Testing
- Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)
- Volunteers
- 113 people
- Sponsor
- Schering-Plough
Diphtheria, Tetanus
The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks
The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT03931239
- Testing
- Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval
- Where
- Vietnam
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Vabiotech
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.
- Trial name
- ASTRAL-5 (NCT02480712)
- Testing
- SOF/VEL
- Where
- 15 sites in United States
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Healthy Participants
A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants
The purpose of this study is to assess the relative bioavailability (the degree to which the study medication becomes available in the blood circulation) of JNJ-47910382, given as an uncoated tablet and as a suspension, after a…
- Trial name
- NCT01662661
- Testing
- JNJ-47910382 (suspension), JNJ-47910382 (tablet)
- Where
- Belgium
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Hepatitis C Virus
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for…
- Trial name
- NCT01188772
- Testing
- Sofosbuvir, PEG, RBV
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 147 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
- Trial name
- NCT00410072
- Testing
- Entecavir, Entecavir + Tenofovir
- Where
- 68 sites in United States, Argentina and 11 more
- Volunteers
- 669 people
- Sponsor
- Bristol-Myers Squibb
Haemophilus Influenzae Type b
Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™
In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio).
- Trial name
- NCT01061541
- Testing
- Tritanrix™-HepB low thio /, Hib 2.5, Tritanrix™-HepB
- Where
- Philippines
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Phase II Dose Response Study in Japan in Chronic Hepatitis B
To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22
- Trial name
- NCT01022801
- Testing
- Entecavir
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C
Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated.
- Trial name
- NCT02112942
- Testing
- IDX21459
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.
- Trial name
- NCT02392494
- Testing
- MK-1075
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
- Trial name
- NCT00697242
- Testing
- Engerix™-B, Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
- Where
- 4 sites in Austria, Belgium and 2 more
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with…
- Trial name
- NCT05484466
- Testing
- ZM-H1505R, Baraclude
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
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