Clinical trials: Disorders of Biliary Tract
Cholestasis, Extrahepatic
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
- Trial name
- NCT00433771
- Testing
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Where
- 10 sites in United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation
Cholestasis
Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat
Absorption, metabolism and excretion of linerixibat have been studied in previous clinical trials. However, no dedicated clinical studies of drug absorption, metabolism, and excretion have been conducted for linerixibat.
- Trial name
- NCT03992014
- Testing
- Linerixibat tablet, [14C]-linerixibat intravenous infusion, Linerixibat oral solution
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Sclerosing Cholangitis (PSC)
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.
- Trial name
- NCT03333928
- Testing
- HTD1801
- Where
- 26 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult
- Trial name
- NCT07020221
- Testing
- VS-7375, Cetuximab, Carboplatin + Pemetrexed + Pembrolizumab
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 616 people
- Sponsor
- Verastem, Inc.
Irritable Bowel Syndrome, Gallstone Disease
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in…
- Conditions
- Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia
- Trial name
- NCT07421011
- Testing
- Trimedat®
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Primary Sclerosing Cholangitis
Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis
The objective of this study is to evaluate the improvement of bile duct strictures following the administration of HK-660S in patients with Primary Sclerosing Cholangitis(PSC).
- Trial name
- NCT05866809
- Testing
- HK-660S
- Where
- 4 sites in South Korea
- Volunteers
- 23 people
- Sponsor
- CuromeBiosciences
Biliary Atresia
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).
- Trial name
- EMBARK (NCT04524390)
- Testing
- Maralixibat
- Where
- 22 sites in United States, China and 6 more
- Volunteers
- 75 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis (PSC)
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
- Trial name
- NCT06699121
- Testing
- LB-P8 low-dose, LB-P8 high-dose
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- LISCure Biosciences
Advanced Solid Tumor, Cholangiocarcinoma
Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Cholangiocarcinoma, HER2-negative Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT04742959
- Testing
- TT-00420, Nab-Paclitaxel
- Where
- 6 sites in United States
- Volunteers
- 203 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Advanced Solid Tumors, Biliary Tract Cancer
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid…
- Trial name
- NCT03440450
- Testing
- FF-10832 Gemcitabine Liposome Injection
- Where
- 7 sites in United States
- Volunteers
- 90 people
- Sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
Primary Biliary Cirrhosis (PBC)
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT02609048
- Testing
- Experimental: Seladelpar 50 mg, Experimental: Seladelpar / MBX-8025 200 mg
- Where
- 49 sites in United States, Canada and 3 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
Uterine Neoplasms, Uterine Cervical Neoplasms
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the…
- Conditions
- Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms
- Trial name
- NCT04579380
- Testing
- tucatinib, trastuzumab, fulvestrant
- Where
- 108 sites in United States, Belgium and 6 more
- Volunteers
- 217 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Liver Cirrhosis, Biliary
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)
- Trial name
- NCT00406237
- Testing
- tigecycline
- Where
- 3 sites in United States, Puerto Rico
- Volunteers
- 8 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Progressive Familial Intrahepatic Cholestasis
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for…
- Trial name
- NCT04483531
- Testing
- Odevixibat
- Where
- United States
- Sponsor
- Albireo
Biliary Atresia
Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy
This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy).
- Trial name
- NCT06121375
- Testing
- OCA
- Where
- 24 sites in Australia, Canada and 8 more
- Volunteers
- 28 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC).
- Trial name
- EPICS (NCT03112681)
- Testing
- Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Zydus Therapeutics Inc.
Alagille Syndrome
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
- Trial name
- ASSERT (NCT04674761)
- Testing
- Odevixibat
- Where
- 32 sites in United States, Belgium and 11 more
- Volunteers
- 52 people
- Sponsor
- Albireo
Neoplasm Malignant, Gastric Neoplasms
A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44/KEYNOTE-G44)
The goal of this study is to assess the safety of pembrolizumab with chemotherapy or chemoradiotherapy in participants in India for: Advanced gastric or gastroesophageal junction [GEJ] cancer that is (human epidermal growth…
- Conditions
- Neoplasm Malignant, Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma, Biliary Tract Carcinoma
- Trial name
- NCT07801027
- Testing
- Pembrolizumab, Cisplatin, 5-Fluorouracil
- Volunteers
- 150 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Solid Tumors, Ewing Sarcoma
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
- Conditions
- Advanced Solid Tumors, Ewing Sarcoma, Hepatocellular Carcinoma (HCC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07197554
- Testing
- ST-01156
- Where
- 6 sites in United States
- Volunteers
- 171 people
- Sponsor
- SEED Therapeutics, Inc.
Biliary Tract Diseases
SpyGlass Direct Visualization System Clinical Registry in China
To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice. Prospective, Post market, Multi-center, Non-randomized Study
- Trial name
- SpyChina (NCT02287194)
- Testing
- SpyGlass
- Where
- China
- Volunteers
- 197 people
- Sponsor
- Boston Scientific Corporation