Clinical trials: Digestive Tract Diseases
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- MARCH-PFIC (NCT03905330)
- Testing
- Maralixibat
- Where
- 31 sites in United States, Argentina and 15 more
- Volunteers
- 93 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cystic Fibrosis
Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease, and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of decline of pulmonary function.
- Trial name
- NCT00531882
- Testing
- Pioglitazone, Simvastatin, Ibuprofen
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Alpha1-antitrypsin Deficiency, Healthy Volunteers
GLASSIA Infusion Rate Study
The purpose of this study was to generate sufficient safety and tolerability information in support of an increase in the infusion rate of intravenous GLASSIA in the prescribing information from 0.04 to 0.2 mL/kg/min.
- Trial name
- NCT01651351
- Testing
- Alpha1-proteinase inhibitor
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Baxalta now part of Shire
Diphtheria, Tetanus
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01444781
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hypercholesterolemia
Effect of Beta-Glucan on Cholesterol Lowering
The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed.
- Trial name
- NCT01408719
- Testing
- Control, 3g LMW beta-glucan, 5g LMW beta-glucan
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Pleural Effusion
Catheter Placement for Hepatic Hydrothorax
The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to conventional medical therapy.
- Trial name
- NCT02595567
- Testing
- Indwelling tunneled pleural catheter (ITPC)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Washington University School of Medicine
Cholestasis, Cholestasis of Parenteral Nutrition
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
- Trial name
- NCT00738101
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 293 people
- Sponsor
- Baylor College of Medicine
Cystic Fibrosis
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for…
- Trial name
- NCT04105972
- Testing
- ELX/TEZ/IVA, TEZ/IVA, IVA
- Where
- 35 sites in Australia, Belgium and 2 more
- Volunteers
- 176 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Laryngopharyngeal Reflux
The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief.
- Trial name
- NCT01317472
- Testing
- dexlansoprazole
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Indiana University
Primary Sclerosing Cholangitis
A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (PSC).
- Trial name
- NCT02978339
- Testing
- Curcumin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- John E. Eaton
Bile Duct Adenocarcinoma, Fanconi Anemia Complementation Group Gene Mutation
Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations.
- Conditions
- Bile Duct Adenocarcinoma, Fanconi Anemia Complementation Group Gene Mutation, Metastatic Bile Duct Carcinoma, PTEN Gene Deletion
- Trial name
- NCT04042831
- Testing
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- Academic and Community Cancer Research United
Hepatopulmonary Syndrome
Letrozole in Patients With Hepatopulmonary Syndrome
The purpose of this study is to assess the safety, tolerability and possible benefit of letrozole compared to placebo in patients with Hepatopulmonary Syndrome.
- Trial name
- NCT04577001
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mayo Clinic
Opioid-Induced Constipation
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer pain.
- Trial name
- NCT01901328
- Testing
- CB-5945
- Volunteers
- 49 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Crohn's Disease
Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation
The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day [BID]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation…
- Trial name
- NCT03850509
- Testing
- OPS-2071
- Where
- 31 sites in United States, Poland
- Volunteers
- 3 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bile Duct Cancer, Intrahepatic Cholangiocarcinoma
Cabozantinib (XL-184) Monotherapy for Advanced Cholangiocarcinoma
This research study is evaluating a drug called cabozantinib as a possible treatment cancer of the bile duct. Cabozantinib is a drug that targets specific pathways inside the cells of the body.
- Conditions
- Bile Duct Cancer, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct
- Trial name
- NCT01954745
- Testing
- Cabozantinib
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Massachusetts General Hospital
Cystic Fibrosis
A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation
To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation
- Trial name
- NCT02742519
- Testing
- ivacaftor
- Where
- 6 sites in Australia, Canada and 1 more
- Volunteers
- 14 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Alagille Syndrome
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and…
- Trial name
- ITCH (NCT02057692)
- Testing
- LUM001
- Where
- 13 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Ulcerative Colitis (UC)
Efficacy & Safety of TD-1473 in Ulcerative Colitis
A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.
- Trial name
- RHEA (NCT03758443)
- Testing
- TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C
- Where
- 188 sites in United States, Australia and 20 more
- Volunteers
- 239 people
- Sponsor
- Theravance Biopharma
Melanoma, Meningioma
T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer
Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, growing them in the laboratory in…
- Conditions
- Melanoma, Meningioma, Breast Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT01967823
- Testing
- Anti-NY ESO-1 mTCR PBL, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Cancer Institute (NCI)
Dysphagia, Pneumonia
Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia
This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark.
- Trial name
- NCT01974089
- Testing
- Dysphagia
- Where
- Denmark
- Volunteers
- 154 people
- Sponsor
- Regionshospital Nordjylland
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