Clinical trials: Digestive Tract Diseases
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Phase 2 Study to Assess the Safety and Efficacy of ANG003
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI).
- Trial name
- NCT07450547
- Testing
- ANG003 Dose A, ANG003 Dose B, Creon
- Where
- 28 sites in United States
- Volunteers
- 113 people
- Sponsor
- Anagram Therapeutics, Inc.
Alpha1-antitrypsin Deficiency
Aralast alpha1-proteinase Inhibitor Surveillance Study
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on…
- Trial name
- NCT00313144
- Testing
- ARALAST Alpha1-Proteinase Inhibitor
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Baxalta now part of Shire
Metastatic Sarcoma, Esophageal Cancer
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to…
- Conditions
- Metastatic Sarcoma, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer
- Trial name
- PHANTOM (NCT06298916)
- Testing
- 64Cu-LNTH-1363S
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Lantheus Medical Imaging
Chronic Hepatitis C
A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3
A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.
- Trial name
- NCT00656006
- Testing
- Albuferon, Ribavirin
- Where
- 6 sites in Canada
- Volunteers
- 43 people
- Sponsor
- Human Genome Sciences Inc.
Autism Spectrum Disorder, Gastrointestinal Dysfunction
ASC - Autism Study
The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived…
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Dysfunction, Leaky Gut Syndrome, Mesenchymal Stromal Cells
- Trial name
- NCT05602116
- Testing
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Cell to Cure ApS
Cystic Fibrosis
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor/ivacaftor (LUM/IVA) in subjects 2…
- Trial name
- NCT02797132
- Testing
- LUM/IVA
- Where
- 20 sites in United States, Canada
- Volunteers
- 62 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Chronic Hepatitis B
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
- Trial name
- NCT00140725
- Testing
- Lamivudine plus Polyethylene glyco-interferon alfa-2b, Lamivudine
- Where
- Hong Kong
- Volunteers
- 160 people
- Sponsor
- GlaxoSmithKline
Neoplasms, Neoplasms, Glandular and Epithelial
Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors
The purpose of this study is to evaluate the effect of entinostat on heart rate and other electrocardiogram (ECG) parameters. This study will also evaluate the safety and tolerability of entinostat, as well as pharmacokinetic and…
- Conditions
- Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Bronchial Neoplasms
- Trial name
- NCT02897778
- Testing
- Entinostat
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Syndax Pharmaceuticals
Solid Tumor
Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific…
- Trial name
- NCT03989115
- Testing
- RMC-4630, Cobimetinib, Drug: Osimertinib
- Where
- 24 sites in United States, South Korea
- Volunteers
- 113 people
- Sponsor
- Revolution Medicines, Inc.
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00408317
- Testing
- Ultrase® MT20
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Forest Laboratories
Crohn's Disease
A Study of E6011 in Participants With Active Crohn's Disease
The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.
- Trial name
- NCT03733314
- Testing
- E6011
- Where
- 46 sites in Czechia, Hungary and 3 more
- Volunteers
- 25 people
- Sponsor
- EA Pharma Co., Ltd.
Biliary Tract Cancer
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
The primary objective are: To assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda/TS-1. To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as assessed…
- Trial name
- NCT05065957
- Testing
- D07001-softgel capsules + Xeloda (or TS-1), mFOLFOX
- Where
- 5 sites in Taiwan
- Volunteers
- 19 people
- Sponsor
- InnoPharmax Inc.
Advanced Solid Tumors
A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)
This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
- Trial name
- NCT03861793
- Testing
- ALKS 4230, Pembrolizumab
- Where
- 48 sites in United States, Canada and 4 more
- Volunteers
- 116 people
- Sponsor
- Mural Oncology, Inc
Solid Tumor
A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
This was an open-label, nonrandomized, Phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as…
- Trial name
- NCT03085914
- Testing
- Epacadostat, Pembrolizumab, Oxaliplatin
- Where
- 16 sites in United States
- Volunteers
- 70 people
- Sponsor
- Incyte Corporation
Cholestasis
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT02966834
- Testing
- GSK2330672
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 147 people
- Sponsor
- GlaxoSmithKline
Advanced Solid Tumors, Gastric Cancer
PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors
The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab. The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate…
- Conditions
- Advanced Solid Tumors, Gastric Cancer, Gastroesophageal Junction Cancer, Urothelial Cancer
- Trial name
- NCT05233436
- Testing
- PF-07265028, Sasanlimab
- Where
- 8 sites in United States, Japan
- Volunteers
- 21 people
- Sponsor
- Pfizer
Primary Sclerosing Cholangitis (PSC)
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and…
- Trial name
- AESOP (NCT02177136)
- Testing
- Obeticholic Acid (OCA)
- Where
- 36 sites in United States, Italy
- Volunteers
- 77 people
- Sponsor
- Intercept Pharmaceuticals
Acquired Immunodeficiency Syndrome, Healthy Volunteers
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea
This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of…
- Conditions
- Acquired Immunodeficiency Syndrome, Healthy Volunteers, HIV/AIDS, HIV Diarrhea
- Trial name
- NCT04192487
- Testing
- Crofelemer delayed-release tablets 125mg
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Napo Pharmaceuticals, Inc.
Chronic Hepatitis B
Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and…
- Trial name
- NCT00964665
- Testing
- albinterferon alfa-2b, Pegasys®
- Where
- 12 sites in China, Hong Kong and 3 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients
Study to obtain information about the safety and tolerability of tiotropium bromide administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after…
- Trial name
- NCT02172534
- Testing
- Tiotropium bromide low, Tiotropium bromide medium, Tiotropium bromide high
- Volunteers
- 113 people
- Sponsor
- Boehringer Ingelheim
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