Clinical trials: Gastrointestinal and Digestive Disorder
Non-alcoholic Steatohepatitis, Hypertriglyceridemia
Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects
This is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) subjects…
- Conditions
- Non-alcoholic Steatohepatitis, Hypertriglyceridemia, Non-alcoholic Fatty Liver Disease, Hypercholesterolemia
- Trial name
- NCT02681055
- Testing
- MN-001
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- MediciNova
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Lung Cancer, Head and Neck Cancer
First-in-human Study of S-588210 (S-488210+S-488211)
The primary objective is to evaluate the safety and tolerability of S-588210 (S-488210+S-488211) in patients with unresectable recurrent and/or metastatic solid tumors.
- Conditions
- Lung Cancer, Head and Neck Cancer, Bladder Cancer, Esophageal Cancer
- Trial name
- NCT04316689
- Testing
- S-488210, S-488211
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Shionogi
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis Delta Virus, Hepatitis D
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants
This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A.
- Trial name
- NCT06740474
- Testing
- ABI-6250
- Where
- New Zealand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
Colitis, Ulcerative
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative…
- Trial name
- NCT00503243
- Testing
- Delayed and extended release mesalazine
- Where
- United States
- Volunteers
- 280 people
- Sponsor
- Shire
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys…
- Trial name
- NCT01185860
- Testing
- danoprevir, peginterferon alfa-2a [Pegasys], ribavirin
- Where
- 4 sites in France, New Zealand and 1 more
- Volunteers
- 59 people
- Sponsor
- Hoffmann-La Roche
Cachexia, Non-Small-Cell Lung Cancer
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
- Conditions
- Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT04299048
- Testing
- PF-06946860
- Where
- 10 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pfizer
Head and Neck Cancer, Malignant Melanoma
GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or…
- Conditions
- Head and Neck Cancer, Malignant Melanoma, Colorectal Cancer, Renal Cell Carcinoma
- Trial name
- NCT06265025
- Testing
- GM103 (Part A), GM103 (Part B), GM103 and Pembrolizumab (Part C)
- Where
- 4 sites in South Korea
- Volunteers
- 125 people
- Sponsor
- GeneMedicine Co., Ltd.
Hepatitis C Virus Infection
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with…
- Trial name
- NCT02536313
- Testing
- SOF/VEL/VOX, RBV
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Gilead Sciences
Crohn's Disease
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease
This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled, sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 3…
- Trial name
- NCT02249078
- Testing
- E6011
- Sponsor
- Eisai Inc.
Hepatitis C, Chronic Pain
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve…
- Trial name
- NCT01215643
- Testing
- Alisporivir, Peginterferon alfa-2a, Ribavirin
- Where
- 73 sites in United States, Australia and 12 more
- Volunteers
- 340 people
- Sponsor
- Debiopharm International SA
Chronic Hepatitis C
Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C
A Phase 2, randomized, double-blind, parallel design trial of two doses of mitoquinone mesylate (MitoQ) and of placebo in patients with chronic Hepatitis C.
- Trial name
- NCT00433108
- Testing
- Mitoquinone mesylate (MitoQ)
- Where
- 2 sites in New Zealand
- Volunteers
- 30 people
- Sponsor
- Antipodean Pharmaceuticals, Inc.
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
- Trial name
- STELLAR-311 (NCT06943755)
- Testing
- Zanzalintinib, Everolimus
- Where
- 135 sites in United States, Australia and 16 more
- Volunteers
- 440 people
- Sponsor
- Exelixis
Gastric Carcinoma
A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment…
- Trial name
- NCT07315750
- Testing
- Disitamab Vedotin, Tislelizumab, CAPOX (oxaliplatin/capecitabine)
- Where
- China
- Volunteers
- 555 people
- Sponsor
- RemeGen Co., Ltd.
Irritable Bowel Syndrome
Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
- Trial name
- ROMERUS (NCT03549143)
- Testing
- IBS
- Where
- 37 sites in Russia
- Volunteers
- 1,000 people
- Sponsor
- Abbott
Colorectal Cancer, Rectal Cancer
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
- Conditions
- Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
- Trial name
- SAFE-2 (NCT05010850)
- Testing
- Colovac, Stoma Creation
- Where
- 16 sites in United States, Belgium and 1 more
- Volunteers
- 18 people
- Sponsor
- SafeHeal Inc
Pancreatic Neoplasms
Gemcitabine, Oxaliplatin and Radiotherapy in Treating Patients With Completely Resected Pancreatic Cancer
A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.
- Trial name
- NCT00191568
- Testing
- Gemcitabine, Oxaliplatin, Radiotherapy
- Where
- 6 sites in France
- Volunteers
- 45 people
- Sponsor
- Eli Lilly and Company
Haemophilus Influenzae Type b, Tetanus
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
The purpose of the study is as follows: To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study…
- Conditions
- Haemophilus Influenzae Type b, Tetanus, Whole Cell Pertussis, Hepatitis B
- Trial name
- NCT00317174
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- Philippines
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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