Clinical trials: Gastrointestinal Infections
HCV Infection
Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
- Trial name
- NCT00850044
- Testing
- ABT-450, ritonavir
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- AbbVie
Hepatitis, Hepatitis C
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to…
- Trial name
- NCT01740089
- Testing
- Algeron, PegIntron, Ribavirin
- Where
- Russia
- Volunteers
- 150 people
- Sponsor
- Biocad
Chronic Hepatitis B
A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied.
- Trial name
- NCT04846491
- Testing
- Peginterferon alfa-2b injection, TDF
- Where
- 33 sites in China
- Volunteers
- 475 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatitis B
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
Open-label pharmacokinetic drug interaction study.
- Trial name
- NCT00644761
- Testing
- Adefovir Dipivoxil
- Where
- 11 sites in United States
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in…
- Trial name
- NCT02932150
- Testing
- TAF
- Where
- 39 sites in United States, Belgium and 6 more
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients…
- Trial name
- NCT01728324
- Testing
- Ribavirin: 24-week treatment, BI 207127: 24-week treatment, Faldaprevir: 24-week treatment
- Where
- 109 sites in United States, Australia and 10 more
- Volunteers
- 496 people
- Sponsor
- Boehringer Ingelheim
Hepatitis A
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".
- Trial name
- NCT01838070
- Where
- South Korea
- Volunteers
- 614 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
Infection
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily…
- Trial name
- NCT01690559
- Testing
- Cipro (Ciprofloxacin, BAYQ3939)
- Where
- Japan
- Volunteers
- 704 people
- Sponsor
- Bayer
Infections, Rotavirus, Rotavirus Vaccines
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
- Trial name
- NCT00969228
- Testing
- Rotarix ™
- Where
- 18 sites in South Korea
- Volunteers
- 684 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Liver Transplantation
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver…
- Trial name
- NCT01131065
- Testing
- Hepatitis B immune globulin
- Where
- 4 sites in Italy
- Volunteers
- 15 people
- Sponsor
- Instituto Grifols, S.A.
Hepatitis C, Chronic
PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or…
- Trial name
- NCT01066819
- Testing
- Peginterferon alfa-2a [Pegasys], Peginterferon alfa-2b [PegIntron®]
- Where
- 106 sites in United States, Puerto Rico
- Volunteers
- 1,656 people
- Sponsor
- Hoffmann-La Roche
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
POCone-UBiT-IR300 Pediatric Comparison Study
The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring 13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath test) Kit and the pUHR-CA web-based software…
- Trial name
- NCT01623154
- Testing
- Pranactin citric solution
- Where
- 3 sites in United States
- Volunteers
- 99 people
- Sponsor
- Otsuka America Pharmaceutical
HIV Infection, Hepatitis C Infection
Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam
With the advent of direct acting antiviral (DAA) treatment in 2013, HCV elimination has become feasible. Still, achieving HCV elimination in resource-limited countries appears to be arduous as several challenges need to be…
- Trial name
- MOVIDA-Hep2 (NCT05506475)
- Testing
- Blood samples
- Where
- 2 sites in Vietnam
- Volunteers
- 400 people
- Sponsor
- Institut Pasteur
Chronic Hepatitis B Infection
Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment…
- Trial name
- NCT07342881
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Hepatitis B, Polio
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00315055
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis C, Hepatitis C (HCV)
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults…
- Conditions
- Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a
- Trial name
- NCT02476617
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 25 people
- Sponsor
- AbbVie
HCV Infection
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of…
- Trial name
- NCT00890318
- Testing
- ABT-072, ketoconazole
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Abbott
Hepatitis C
A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects
This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals
- Trial name
- NCT02760758
- Testing
- CDI-31244
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Cocrystal Pharma, Inc.
Hepatitis C, Chronic
Dose Ranging of GSK2336805 in Combination Therapy
GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection.
- Trial name
- HAI115879 (NCT01648140)
- Testing
- GSK2336805 40 mg, GSK2336805 60 mg, Pegylated interferon alpha-2a
- Where
- 34 sites in United States, Belgium and 4 more
- Volunteers
- 286 people
- Sponsor
- GlaxoSmithKline
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