Clinical trials: Gastrointestinal and Digestive Disorder
Carcinoma, Hepatocellular, Liver Metastases
Study to Evaluate VORTX Rx (Theresa)
Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors
- Trial name
- Theresa (NCT03741088)
- Testing
- VORTX Rx treatment
- Where
- 3 sites in Spain
- Volunteers
- 8 people
- Sponsor
- HistoSonics, Inc.
Colitis, Ulcerative
An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
- Trial name
- NCT02497469
- Testing
- Vedolizumab, Adalimumab
- Where
- 330 sites in United States, Argentina and 32 more
- Volunteers
- 771 people
- Sponsor
- Takeda
Gastric Cancer, Gastroesophageal Junction Cancer
GRACE-DE: Prospective Multicenter Real-world Gastric Cancer Patients Starting AZ-developed and Approved Drugs in Germany (Umbrella Study)
This is a prospective, non-interventional, observational, multicentre study evaluating the real-world effectiveness and safety of AstraZeneca-developed and approved medicines used to treat gastric and/or oesophageal cancers in…
- Trial name
- GRACE-DE (NCT07882212)
- Volunteers
- 300 people
- Sponsor
- AstraZeneca
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.
Acid Reflux, Gastro Oesophageal Reflux Disease
A Three-Period Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions
The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions.
- Trial name
- NCT01710995
- Testing
- Zegerid, Losec
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Norgine
Hepatic Encephalopathy, Urea Cycle Disorders
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
The purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic impairment with cirrhosis (Child-Pugh scores of…
- Trial name
- NCT00986895
- Testing
- HPN-100
- Where
- 2 sites in Ukraine
- Volunteers
- 32 people
- Sponsor
- Amgen
Stomach Neoplasms
A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer
The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world…
- Trial name
- G-KNIGHT (NCT05334719)
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Bristol-Myers Squibb
NASH - Nonalcoholic Steatohepatitis
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
- Trial name
- NCT03748628
- Testing
- EDP-305
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
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
Colorectal Cancer (Locally Advanced or Metastatic)
A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer
SOT109 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called CDH17, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B.
- Trial name
- NCT07693751
- Testing
- SOT109
- Where
- 3 sites in United States, Moldova
- Volunteers
- 100 people
- Sponsor
- SOTIO Biotech a.s.
Ulcerative Colitis
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
- Trial name
- PROTECT-2 (NCT02280629)
- Testing
- LT-02, Mesalamine
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Dr. Falk Pharma GmbH
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
Urea Cycle Disorder, Crigler-Najjar Syndrome
HepaStem Long-Term Safety Registry
All patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera Biosciences
- Conditions
- Urea Cycle Disorder, Crigler-Najjar Syndrome, Acute on Chronic Liver Failure
- Trial name
- PROLONGSTEM (NCT03343756)
- Where
- 29 sites in Belgium, Bulgaria and 3 more
- Volunteers
- 44 people
- Sponsor
- Cellaion SA
Cystic Fibrosis, Advanced Lung Disease
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation
- Trial name
- NCT02390219
- Testing
- Lumacaftor, Ivacaftor
- Where
- 6 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Microscopic Colitis
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis.
- Trial name
- NCT07156175
- Testing
- SAR444336
- Where
- 24 sites in Belgium, Denmark and 7 more
- Volunteers
- 54 people
- Sponsor
- Sanofi
Fatigue Related to Cancer Treatment, Colon Cancer
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy.
The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.
- Trial name
- NuvastaticTM (NCT07669454)
- Testing
- Nuvastatic 300
- Where
- 6 sites in India
- Volunteers
- 250 people
- Sponsor
- Natureceuticals Sdn Bhd
Short Bowel Syndrome, Malabsorption Syndromes
Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)
A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC)…
- Conditions
- Short Bowel Syndrome, Malabsorption Syndromes, Short Gut Syndrome, Post-Op Complication
- Trial name
- CRO-SBS-IF (NCT06904872)
- Testing
- Crofelemer Powder for Oral Solution
- Where
- 8 sites in Germany, Italy
- Volunteers
- 18 people
- Sponsor
- Napo Therapeutics, S.p.A.
Cystic Fibrosis
Rollover Study of VX-770 in Cystic Fibrosis Subjects
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF).
- Trial name
- NCT01117012
- Testing
- Ivacaftor
- Where
- 58 sites in United States, Australia and 6 more
- Volunteers
- 192 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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