Clinical trials: Digestive Disease
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
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
Colorectal Cancer
CRC Post-surgical Assessment and Recurrence Monitoring
The surgical therapeutic effect of stage II-IV CRC patients will be assessed by the plasma mSEPT9 assay, and patients will be followed up by the same assay for recurrence monitoring.
- Trial name
- NCT03334890
- Testing
- plasma mSEPT9 level
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- BioChain (Beijing) Science and Technology, Inc.
Irritable Bowel Syndrome
The Efficacy of Sodium Butyrate and Probiotics in Patients With Irritable Bowel Syndrome
According to current IBS management guidelines, probiotic administration reduces IBS-associated symptoms and improves the quality of life.
- Trial name
- IBS-Plus (NCT05013060)
- Testing
- Probiotics and microcapsulated sodium butyrate, Maltodextrin
- Where
- Poland
- Volunteers
- 120 people
- Sponsor
- Nordic Biotic Sp. z o.o.
Liver Cancer (Primary and Metastatic)
Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
The SEGWAY trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of flow diversion to protect non-tumorous liver function using short-acting gelatin sponge particles during Yttrium-90…
- Trial name
- SEGWAY (NCT06229080)
- Testing
- NexGel
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Next Biomedical Co., Ltd.
Hepatitis C, Chronic, Hepatitis C
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults.
- Trial name
- NCT00439959
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.
- Trial name
- OPAL (NCT02808780)
- Where
- 63 sites in United States, Austria and 7 more
- Volunteers
- 535 people
- Sponsor
- Janssen Biotech, Inc.
Irritable Bowel Syndrome (IBS)
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the emptying of the colon and increases total colonic transit time.
- Trial name
- NCT00401479
- Testing
- Solabegron (GW427353)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cancer
Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer
This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma…
- Trial name
- NCT02301962
- Testing
- Panitumumab
- Where
- 12 sites in India
- Volunteers
- 58 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Gastrointestinal Neoplasms, Adenocarcinoma
A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer
The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131.
- Trial name
- NCT02795988
- Testing
- IMU-131, Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.
- Where
- 22 sites in Georgia, India and 5 more
- Volunteers
- 64 people
- Sponsor
- Imugene Limited
Cystic Fibrosis
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del…
- Trial name
- NCT03525574
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 110 sites in United States, Australia and 11 more
- Volunteers
- 507 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
EGFR Overexpression, Locally Advanced Solid Tumor
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can…
- Conditions
- EGFR Overexpression, Locally Advanced Solid Tumor, Metastatic Solid Tumor
- Trial name
- NCT06975410
- Testing
- YH32364
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Yuhan Corporation
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