Clinical trials: Disorders of Biliary Tract
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Primary Biliary Cirrhosis
Pilot Study of FFP104 Dose Escalation in PBC Subjects
The purpose of this study is to determine the initial safety, tolerability and pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC
- Trial name
- NCT02193360
- Testing
- FFP104
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Fast Forward Pharmaceuticals
Gastrointestinal Cancer, Biliary Tract Cancer
Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase
Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI)…
- Trial name
- NCT03531320
- Testing
- D07001-softgel capsules
- Where
- 4 sites in Taiwan
- Volunteers
- 19 people
- Sponsor
- InnoPharmax Inc.
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Bile Duct Cancer
Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials
Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.
- Trial name
- NCT05706974
- Volunteers
- 500 people
- Sponsor
- Power Life Sciences Inc.
Primary Biliary Cholangitis (PBC)
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone…
- Trial name
- NCT07304843
- Testing
- golexanolone
- Where
- 38 sites in Germany, Greece and 6 more
- Volunteers
- 207 people
- Sponsor
- Umecrine Cognition AB
Melanoma, Breast Carcinoma
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity…
- Conditions
- Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma
- Trial name
- DUET-2 (NCT03517488)
- Testing
- XmAb20717
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Xencor, Inc.
Advanced Biliary Tract Cancer, Biliary Tract Cancer (BTC)
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer
This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over…
- Trial name
- Beacon-BTC (NCT07265674)
- Testing
- Nanvuranlat, Physician's Best Choice
- Where
- 18 sites in United States
- Volunteers
- 480 people
- Sponsor
- J-Pharma Co., Ltd.
Biliary Cirrhosis, Primary
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials.
- Trial name
- NCT02932449
- Where
- 39 sites in United States
- Volunteers
- 711 people
- Sponsor
- Target PharmaSolutions, Inc.
Primary Sclerosing Cholangitis
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT04024813
- Testing
- Seladelpar
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1 people
- Sponsor
- Gilead Sciences
Primary Biliary Cirrhosis
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04956328
- Testing
- Obeticholic Acid Tablets, UDCA
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects.
- Conditions
- Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
- Trial name
- NCT02963077
- Testing
- A4250, CRC (A3384), Questran
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Albireo
Cancer of Pancreas, Cancer of Liver
A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies
A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center Study to Assess the Efficacy of BRCX014 Combined with Standard-Of-Care Treatment in Subjects with Glioblastoma Multiforme, Multiple Myeloma, and GI…
- Conditions
- Cancer of Pancreas, Cancer of Liver, Cancer of Rectum, Cancer of Colon
- Trial name
- NCT03607643
- Testing
- Cannabidiol, Bortezomib, Leucovorin
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Leaf Vertical Inc.
Alagille Syndrome
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives.
- Trial name
- NCT06850038
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
Gastrointestinal Cancer, Pancreatic Cancer
Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies
The primary objective of this prospective observational study is to characterize the gut and oral microbiome as well as the whole blood transcriptome in gastrointestinal cancer patients and correlate these findings with cancer…
- Conditions
- Gastrointestinal Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer
- Trial name
- NCT05462314
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Viome
Primary Biliary Cholangitis
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects…
- Trial name
- NCT05190523
- Testing
- ASC42 5 mg, ASC42 10 mg, ASC42 15 mg
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Gannex Pharma Co., Ltd.
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT01949870
- Testing
- Cisplatin, Gemcitabine, Selumetinib
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Prostate Cancer, Cholelithiases
A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System
The goal of this clinical trial is to test the safety and effectiveness of the Medtronic Hugo™ RAS System in patients undergoing a prostatectomy or a cholecystectomy.
- Conditions
- Prostate Cancer, Cholelithiases, Cholecystitis, Gallbladder Polyp
- Trial name
- NCT05715827
- Testing
- RAS prostatectomy and RAS cholecystectomy
- Where
- South Korea
- Volunteers
- 42 people
- Sponsor
- Medtronic - MITG