Clinical trials: Digestive System
Alpha 1-Antitrypsin Deficiency
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype
This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-814 in PiZZ subjects.
- Trial name
- NCT04167345
- Testing
- VX-814
- Where
- 28 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis B
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in…
- Trial name
- NCT00697931
- Testing
- Recombinant MPL- adjuvanted hepatitis B vaccine, Engerix™-B
- Where
- Belgium
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Metastatic Pancreatic Cancer
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients…
- Trial name
- NCT06532331
- Testing
- ONO-7475, ONO-4538, Nab-paclitaxel
- Where
- 9 sites in Japan
- Volunteers
- 87 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Gastroesophageal Reflux Disease
Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).
- Trial name
- NCT01574339
- Testing
- EndoStim LES Stimulation System
- Where
- 10 sites in Chile, Colombia and 6 more
- Volunteers
- 42 people
- Sponsor
- EndoStim Inc.
Inflammatory Bowel Disease, Perianal Fistula
Perianal Fistula (PAF) Validation and Burden of Illness Study
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
- Trial name
- NCT03981939
- Testing
- No intervention
- Where
- Canada
- Volunteers
- 3,032 people
- Sponsor
- Takeda
Ulcerative Colitis (UC)
Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis
An open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of TLA Gut™ leukapheresis treatment in patients with UC.
- Trial name
- NCT04550130
- Testing
- TLA Gut™
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- TLA, Targeted Immunotherapies AB
Colorectal Neoplasms
An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.
- Trial name
- NCT01134666
- Testing
- Cetuximab
- Where
- 40 sites in India
- Volunteers
- 165 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Colorectal Cancer (CRC)
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
- Trial name
- NCT00851045
- Testing
- Irinotecan, 5-Fluorouracil (bolus), 5-Fluorouracil (infusional)
- Where
- 15 sites in United States, Argentina and 1 more
- Volunteers
- 17 people
- Sponsor
- Bristol-Myers Squibb
Cystic Fibrosis
Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)
Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific metabolites involved in the resolution of inflammation.
- Trial name
- PREMDIC (NCT02518672)
- Testing
- MAG-DHA
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- SCF Pharma
NASH, Cirrhosis, Liver
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical…
- Trial name
- NCT05500222
- Testing
- Resmetirom
- Where
- 141 sites in United States, Belgium and 7 more
- Volunteers
- 845 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Drug Interaction, GERD (Gastroesophageal Reflux Disease)
A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin
This is an open, single arm, single-center Phase I trial designed to evaluate the effect of seven days repeated oral doses of linaprazan glurate on the pharmacokinetics (PK) of repeated doses of amoxicillin in healthy male and…
- Conditions
- Drug Interaction, GERD (Gastroesophageal Reflux Disease), Safety, and Tolerability
- Trial name
- NCT07308041
- Testing
- Drug Drug Interaction
- Where
- Sweden
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Hepatocellular Carcinoma
Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized…
- Trial name
- OPTIMA (NCT02112656)
- Testing
- ThermoDox, Dummy infusion
- Where
- 61 sites in United States, Canada and 12 more
- Volunteers
- 554 people
- Sponsor
- Imunon
Squamous Cell Carcinoma of the Anal Canal
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
- Trial name
- NCT04472429
- Testing
- carboplatin, paclitaxel, retifanlimab
- Where
- 84 sites in United States, Australia and 11 more
- Volunteers
- 308 people
- Sponsor
- Incyte Corporation
Gastrointestinal Function
Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels
The objective of the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (> 70 years age) and another age group (30…
- Trial name
- NCT03910153
- Testing
- MSPrebiotic
- Where
- Canada
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- MSP Starch Products Inc.
Clear Cell Renal Cell Carcinoma, Cervical Carcinoma
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
- Conditions
- Clear Cell Renal Cell Carcinoma, Cervical Carcinoma, Esophageal Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT05795595
- Testing
- CTX131
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- CRISPR Therapeutics AG
Colitis, Ulcerative
A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants
"GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans.
- Trial name
- NCT06681181
- Testing
- GSK4528287
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rift Valley Fever
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
Phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (PK) and immunogenicity of IDB-011 following intramuscular (IM )administration of single ascending doses to healthy…
- Trial name
- NCT06925919
- Testing
- IDB-011 dose level 1, IDB-011 dose level 2, IDB-011 dose level 3
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IDBiologics, Inc.
Advanced Solid Tumors, Glioblastoma
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors
Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.
- Conditions
- Advanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST), Endometrial Carcinoma
- Trial name
- NCT02611024
- Testing
- Lurbinectedin, Irinotecan
- Where
- 23 sites in United States, France and 4 more
- Volunteers
- 316 people
- Sponsor
- PharmaMar
Oral Mucositis
Study of Dentoxol® Mouthrinse for Oral Mucositis
The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.
- Trial name
- NCT02885376
- Testing
- Dentoxol
- Where
- 3 sites in Chile
- Volunteers
- 108 people
- Sponsor
- Ingalfarma SpA
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