Clinical trials: Digestive Disease
Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Metastatic
Phase 1 Trial of ACE723, A Dual-Payload Antibody Drug Conjugate, in Patients With Advanced HCC Who Have Failed or Progressed on Standard Systemic Therapy Containing ICIs
ACE723 is a dual-payload antibody drug conjugate targeting glypican-3 (GPC-3) that is under investigation for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
- Conditions
- Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Metastatic, Hepatocellular Carcinoma Non-Resectable
- Trial name
- NCT07861425
- Testing
- ACE723
- Where
- 2 sites in China
- Volunteers
- 70 people
- Sponsor
- Acepodia Biotech, Inc.
Gastrointestinal Bleeding
Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure
Development of a new diagnostic detection tool for gastrointestinal bleeding.
- Trial name
- NCT01267318
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Medtronic - MITG
Locally Advanced Pancreatic Adenocarcinoma
Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
- Trial name
- NCT03077685
- Testing
- NanoPac®
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- NanOlogy, LLC
Barrett Esophagus
Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years
This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue.
- Trial name
- AIM (NCT00489268)
- Testing
- HALO Ablation System
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 102 people
- Sponsor
- Covidien, GI Solutions
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
Alpha 1-Antitrypsin Deficiency
Pharmacokinetic Study of ARALAST (Human Alpha1- PI)
The primary purpose of this study is to characterize the pharmacokinetic profile of intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of functionally intact human Alpha1- Proteinase Inhibitor…
- Trial name
- NCT00242385
- Testing
- Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor, Dose of 60 mg/kg alpha1-proteinase inhibitor
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 25 people
- Sponsor
- Baxalta now part of Shire
Malignant Ascites
Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.
- Trial name
- NCT00326885
- Testing
- catumaxomab
- Where
- 18 sites in United States
- Volunteers
- 32 people
- Sponsor
- Neovii Biotech
Advanced Solid Tumors, Breast Cancer Recurrent
First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients With Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers
The goal of this study is to identify a safe and tolerated dose of the orally administered DHX9 inhibitor ATX-559. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of…
- Conditions
- Advanced Solid Tumors, Breast Cancer Recurrent, Colorectal Cancer Metastatic, Colon Cancer
- Trial name
- NCT06625515
- Testing
- ATX-559
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Accent Therapeutics
Hepatitis B
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
- Trial name
- NCT00697125
- Testing
- Engerix™-B, HBV-MPL vaccine (208129), Hepatitis B vaccine, experimental formulation
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pruritus
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function.
- Trial name
- NCT05393076
- Testing
- Linerixibat
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pancreatic Ductal Adenocarcinoma
Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer
Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around…
- Trial name
- NCT01580397
- Testing
- INNO-206
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- ImmunityBio, Inc.
Rectal Cancer Surgery
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current…
- Trial name
- NCT07429110
- Testing
- ColoSeal ICD System, Protective Diverting Ostomy
- Where
- 9 sites in United States, New Zealand
- Volunteers
- 250 people
- Sponsor
- Averto Medical, Inc.
Hepatitis A, Viral Hepatitis Vaccines
Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.
- Trial name
- NCT02112890
- Testing
- Data collection
- Where
- Mexico
- Volunteers
- 1,603 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Anal Fistula
Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease
Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas.
- Trial name
- FATT1 (NCT00475410)
- Testing
- ASCs (Cx401, company code), Fibrin adhesive
- Where
- 10 sites in Germany, Spain and 1 more
- Volunteers
- 214 people
- Sponsor
- Tigenix S.A.U.
Solid Tumor, HER-2 Protein Overexpression
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting…
- Trial name
- NCT03680560
- Testing
- ACTR T Cell Product, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Cogent Biosciences, Inc.
Hepatitis C Virus Infection
Absolute Bioavailability of BMS-791325
The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.
- Trial name
- NCT02112110
- Testing
- BMS-791325, [13C]-BMS-791325
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Esophageal Squamous Cell Carcinoma
A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
This study is a randomized, double-blind, multi-center, phase III clinical study comparing the clinical efficacy and safety of HLX10 or placebo combined with chemotherapy in first-line treatment of locally advanced/metastatic…
- Trial name
- NCT03958890
- Testing
- HLX10 100 mg in 10 ml Injection
- Where
- 7 sites in China
- Volunteers
- 489 people
- Sponsor
- Shanghai Henlius Biotech
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
Gastric Cancer, Esophageal Cancer
PAN-study: Pan-Cancer Early Detection Study (PAN)
The PAN-cancer Early Detection study or PAN-study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy can differentiate between patients with and without different cancer types by…
- Conditions
- Gastric Cancer, Esophageal Cancer, Liver Cancer
- Trial name
- NCT03756597
- Testing
- ReCIVA, CASPER
- Where
- United Kingdom
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Owlstone Ltd
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