Clinical trials: Gastrointestinal Infection
Hepatitis C, Chronic, Hepatitis C
An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)
This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study.
- Trial name
- PEGIMPACT (NCT00704756)
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Sponsor
- Merck Sharp & Dohme LLC
Pseudomonas Infection
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation.
- Trial name
- NCT00910351
- Testing
- Ciprofloxacin (Cipro, BAYQ3939)
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- Bayer
Chronic Hepatitis B
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the…
- Trial name
- NCT04142762
- Testing
- ABI-H2158, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Liver Fibrosis, Hepatitis C
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
- Conditions
- Liver Fibrosis, Hepatitis C, HIV, HIV/HCV Co-infection
- Trial name
- NCT01707472
- Testing
- Simtuzumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve…
- Trial name
- NCT01483742
- Testing
- RO5024048, danoprevir, peginterferon alfa-2a [Pegasys]
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 43 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection.
- Trial name
- NCT00423670
- Testing
- boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron), ribavirin
- Volunteers
- 765 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus
TMC435-TiDP16-C108 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Digoxin and Between TMC435 and Rosuvastatin
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the single-dose pharmacokinetics of digoxin or rosuvastatin , and the effect of a single dose of digoxin or rosuvastatin on the…
- Trial name
- NCT01288742
- Testing
- Rosuvastatin, TMC435, Digoxin
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis C
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before.
- Trial name
- QUEST-1 (NCT01289782)
- Testing
- TMC435, Peginterferon alpha-2a (PegIFN alpha-2a), Ribavirin (RBV)
- Where
- 62 sites in United States, Australia and 10 more
- Volunteers
- 395 people
- Sponsor
- Janssen R&D Ireland
Hepatitis B
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced.
- Trial name
- NCT00291980
- Testing
- HB-AS02V vaccine, HBVAXPRO vaccine
- Where
- 28 sites in Belgium, Czechia and 1 more
- Volunteers
- 185 people
- Sponsor
- Henogen
Hepatitis C Virus Infection, Response to Therapy of
Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from…
- Trial name
- NCT01473056
- Testing
- JTK-853, Dose 2 JTK-853, Dose 3 JTK-853
- Where
- Puerto Rico
- Volunteers
- 29 people
- Sponsor
- Shionogi Inc.
Hepatitis B, Chronic
A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
- Trial name
- HBV (NCT02499562)
- Testing
- Hydronidone, Entecavir
- Where
- 2 sites in China
- Volunteers
- 168 people
- Sponsor
- Shanghai Genomics, Inc.
Pharyngitis
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore…
- Trial name
- NCT01048866
- Testing
- flurbiprofen, acetaminophen 650mg
- Where
- United States
- Volunteers
- 198 people
- Sponsor
- Reckitt Benckiser LLC
Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
Special Drug Use Investigation of Ciproxan Injection in Pediatrics
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
- Trial name
- NCT02555059
- Testing
- Cipro (Ciprofloxacin, BAYQ3939)
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Bayer
Chronic Hepatitis B
Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B
- Trial name
- NCT01926288
- Testing
- Entecavir maleate tablets, blank Baraclude tablets, Blank maleate entecavir tablets
- Where
- 9 sites in China
- Volunteers
- 287 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Genotype 1 Chronic Hepatitis C
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects.
- Trial name
- NCT00606086
- Testing
- GI-5005, Pegylated Interferon and Ribavirin
- Where
- 25 sites in United States
- Volunteers
- 140 people
- Sponsor
- GlobeImmune
Chronic Hepatitis C(CHC)
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
- Trial name
- NCT01753570
- Testing
- MP-424, RBV(24 weeks), IFN beta(24 weeks)
- Where
- Japan
- Volunteers
- 74 people
- Sponsor
- Tanabe Pharma Corporation
Hepatitis B Infection, Congenital Malformation
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection.
- Conditions
- Hepatitis B Infection, Congenital Malformation, Birth Defect, Viremia
- Trial name
- NCT03476083
- Testing
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Where
- 7 sites in China
- Volunteers
- 280 people
- Sponsor
- New Discovery LLC
Hepatitis C, Liver Cirrhosis
Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)
This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human immunodeficiency virus-hepatitis C virus…
- Conditions
- Hepatitis C, Liver Cirrhosis, HIV Infections
- Trial name
- NCT00381017
- Testing
- Peg interferon alpha-2b
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen
The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.
- Trial name
- NCT00035789
- Testing
- Entecavir
- Where
- 31 sites in United States
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks…
- Trial name
- NCT02350569
- Testing
- LDV/SOF
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Gilead Sciences
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