Clinical trials: Gastrointestinal Infections
Hepatitis A
Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults
A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated…
- Trial name
- NCT01865968
- Testing
- Inactivated HAV vaccine, Live attenuated HAV vaccine
- Where
- China
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hepatitis B
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
- Trial name
- NCT00313274
- Testing
- Clevudine
- Where
- 30 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Bukwang Pharmaceutical
Hepatitis C, Viruses
TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins.
The purpose of this study is to determine whether TMC435 influences the activity of certain drug-degrading proteins in the human body.
- Trial name
- NCT00866853
- Testing
- TMC435
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Infections, Human Immunodeficiency Virus and Hepatitis
Relative Bioavailability Study of GSK1265744 Formulations
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state…
- Trial name
- NCT01648257
- Testing
- GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules, GSK1265744 Free Acid Micronized Capsules
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hepatitis C
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
- Trial name
- NCT00728936
- Testing
- IMO-2125
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 58 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Hepatitis C
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus…
- Trial name
- NCT01896193
- Testing
- SOF, RBV
- Where
- 16 sites in Russia
- Volunteers
- 127 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis
An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.
- Trial name
- NCT00787917
- Testing
- Omalizumab, Itraconazole
- Where
- 10 sites in Belgium, Germany and 3 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis, CF
Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.
- Conditions
- Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- NCT01055847
- Testing
- Aztreonam for Inhalation (AI)
- Where
- 20 sites in United States
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Hepatitis C
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2…
- Trial name
- NCT01808248
- Testing
- SOF, PEG, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Pregnant
DV2-HBV-27: Observational Pregnancy Registry
Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy
- Trial name
- HBV-27 (NCT03664648)
- Testing
- HEPLISAV-B
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Melanoma, Merkel Cell Carcinoma
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable…
- Conditions
- Melanoma, Merkel Cell Carcinoma, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma
- Trial name
- REVEAL (NCT03435640)
- Testing
- NKTR-262, bempegaldesleukin, nivolumab
- Where
- 14 sites in United States
- Volunteers
- 64 people
- Sponsor
- Nektar Therapeutics
Hepatitis C
Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)
This adaptive design study will evaluate the safety, pharmacokinetics, and effect on hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV infection.
- Trial name
- NCT01930058
- Testing
- MK-8876
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects
The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection
- Trial name
- NCT00663208
- Testing
- Daclatasvir
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 167 people
- Sponsor
- Bristol-Myers Squibb
Liver Transplant, Hepatitis C
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver.
- Trial name
- NCT00260208
- Testing
- Cyclosporine A, Tacrolimus
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 361 people
- Sponsor
- Novartis Pharmaceuticals
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
Chronic Hepatitis B Virus Infection
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV).
- Trial name
- NCT07389044
- Testing
- IB-001, Peginterferon Alfa-2A
- Where
- 5 sites in Hong Kong, Moldova and 2 more
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- IntegerBio
Hepatitis B, Hepatitis A
Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years
To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00197119
- Testing
- Twinrix™ Adult, Twinrix™ Junior
- Where
- 2 sites in Belgium, Czechia
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00617812
- Testing
- Shan5
- Where
- 4 sites in India
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
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