Clinical trials: Gastrointestinal Infections
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with…
- Trial name
- NCT01057667
- Testing
- RO5024048, Ribavirin [Copegus], peginterferon alfa-2a [Pegasys]
- Where
- 25 sites in United States, Canada
- Volunteers
- 168 people
- Sponsor
- Hoffmann-La Roche
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
PHASE 1 TRIAL OF Lm-LLO-TT AND GEMCITABINE IN UNRESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA
ClinicalTrials.gov Brief Summary This Phase 1, open-label, first-in-human study is designed to evaluate the safety, tolerability, and recommended dose of intraperitoneal (IP) administration of Lm-LLO-TT in combination with…
- Conditions
- Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer, Advanced Pancreatic Adenocarcinoma
- Trial name
- NCT07828236
- Testing
- Lm-LLO-TT
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Loki Therapeutics, Inc.
End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
- Conditions
- End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis, Peritonitis
- Trial name
- ACT (NCT05285436)
- Testing
- CloudCath System
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- CloudCath
Hepatitis C, Chronic
An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C
This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C.
- Trial name
- NCT01679834
- Where
- 2 sites in Germany
- Volunteers
- 7,500 people
- Sponsor
- Hoffmann-La Roche
Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF)
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing…
- Trial name
- ENCORE (NCT03597347)
- Testing
- Molgramostim nebulizer solution, PARI eFlow nebulizer system
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Savara Inc.
Advanced Solid Tumors, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
- Conditions
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC
- Trial name
- NCT04272034
- Testing
- INCB099318
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Incyte Corporation
Hepatocellular Carcinoma, Squamous Cell Carcinoma of the Lung
BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors
This is a first-in-human (FIH), Phase 1/2, open-label, multicenter study to assess safety and determine the recommended Phase 2 dose (RP2D) of BOXR1030 administration after lymphodepleting chemotherapy (LD chemotherapy) in…
- Conditions
- Hepatocellular Carcinoma, Squamous Cell Carcinoma of the Lung, Merkel Cell Carcinoma, Myxoid/Round Cell Liposarcoma
- Trial name
- DUET-1 (NCT05120271)
- Testing
- CAR-GPC3 T Cells
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- Sotio Biotech Inc.
Hepatitis B
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at…
- Trial name
- NCT00698087
- Testing
- MPL-Adjuvanted recombinant hepatitis B vaccine, Engerix™-B
- Where
- Austria
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C Virus (HCV)
Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
- Trial name
- NCT03341871
- Where
- Japan
- Volunteers
- 1,095 people
- Sponsor
- AbbVie
Chronic Hepatitis C
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients…
- Trial name
- NCT00162734
- Testing
- Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks
- Volunteers
- 144 people
- Sponsor
- Bausch Health Americas, Inc.
Hepatitis C
Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)
This is a Phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor.
- Trial name
- OBSERVER (NCT01426204)
- Volunteers
- 40 people
- Sponsor
- Closter Pharma
Chronic Hepatitis C
Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
- Trial name
- NCT00759200
- Testing
- alb-interferon alfa 2b, peg-interferon
- Where
- 55 sites in Australia, Canada and 10 more
- Volunteers
- 525 people
- Sponsor
- Novartis
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT00614471
- Testing
- Entecavir, peginterferon alfa-2a [Pegasys]
- Where
- 8 sites in China, Hong Kong
- Volunteers
- 219 people
- Sponsor
- Hoffmann-La Roche
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Shigellosis
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella…
- Trial name
- NCT02646371
- Testing
- Flexyn2a
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Hepatitis A, Hep A
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2…
- Trial name
- NCT05613127
- Testing
- Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL, HAVRIX 720 Junior 0.5 mL
- Where
- 2 sites in South Korea, Thailand
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.
Chronic Hepatitis B
Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection
This study uses random, double -blindness, placebo control, and phase multi -center test design. All subjects who meet the standards receive TQ-A3334 per tablet/placebo nucleoside (acid) analog. A total of 116 subjects are needed.
- Trial name
- NCT06706310
- Testing
- TQA3334 Tablet, Nucleoside (acid) analogs (NAs)
- Where
- 15 sites in China
- Volunteers
- 116 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Cirrhosis, Chronic Hepatitis C
Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy…
- Trial name
- NCT00502086
- Testing
- Viusid (nutritional supplement)
- Where
- Cuba
- Volunteers
- 100 people
- Sponsor
- Catalysis SL
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