Clinical trials: Primary Biliary Cholangitis
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
Primary Sclerosing Cholangitis
Pilot Study of Fenofibrate for PSC
The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).
- Trial name
- NCT01142323
- Testing
- fenofibrate
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- University of Miami
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
Primary Sclerosing Cholangitis, Biliary Atresia
Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
The goals of the proposed work are two fold: Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC).
- Trial name
- PSC (NCT01322386)
- Testing
- Vancomycin
- Volunteers
- 32 people
- Sponsor
- Stanford University
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
Primary Sclerosing Cholangitis
CM-101 in PSC Patients -The SPRING Study
This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT04595825
- Testing
- Anti-human CCL24 monoclonal antibody (CM-101)
- Where
- 33 sites in United States, Germany and 3 more
- Volunteers
- 77 people
- Sponsor
- ChemomAb Ltd.
Primary Sclerosing Cholangitis
Vidofludimus Calcium for Primary Sclerosing Cholangitis
To examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period.
- Trial name
- PSC (NCT03722576)
- Testing
- Vidofludimus calcium
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Elizabeth Carey
Primary Biliary Cholangitis (PBC)
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response…
- Trial name
- NCT03124108
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 24 sites in United States, France and 3 more
- Volunteers
- 45 people
- Sponsor
- Genfit
Sclerosing Cholangitis
Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.
This is an open-label single-arm pilot study to measure the safety, microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT02424175
- Testing
- Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Brigham and Women's Hospital
Primary Sclerosing Cholangitis
Vancomycin for Primary Sclerosing Cholangitis
To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis. Funding Source - FDA OOPD
- Trial name
- NCT03710122
- Testing
- Vancomycin
- Where
- 4 sites in United States
- Volunteers
- 102 people
- Sponsor
- Elizabeth Carey
Primary Biliary Cholangitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
- Trial name
- NCT03394924
- Testing
- EDP-305 1 mg, EDP-305 2.5 mg
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Liver Cirrhosis, Biliary
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
- Trial name
- NCT00550862
- Testing
- INT-747, Ursodeoxycholic Acid (URSO)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 165 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
Primary Sclerosing Cholangitis
Trial of High-dose Urso in Primary Sclerosing Cholangitis
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC).
- Trial name
- NCT00059202
- Testing
- Ursodeoxycholic Acid
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary Biliary Cholangitis
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
- Trial name
- NCT02516605
- Testing
- Part 1: LJN452, Part 2: LJN452 Dose level 1, Part 2: LJN452 Dose level 2
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Primary Sclerosing Cholangitis (PSC)
Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis
The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.
- Trial name
- CAMEO (NCT02061540)
- Testing
- LUM001
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis
PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT02653625
- Testing
- Cenicriviroc 150 mg
- Where
- 9 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- Tobira Therapeutics, Inc.
Primary Sclerosing Cholangitis
Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.
- Trial name
- NCT00953615
- Testing
- Thalidomide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mayo Clinic