Clinical trials: PBC
Primary Biliary Cholangitis
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of…
- Trial name
- NCT04620733
- Testing
- Seladelpar 10 mg, Seladelpar 5 mg
- Where
- 134 sites in United States, Argentina and 24 more
- Volunteers
- 193 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).
- Trial name
- NCT03742973
- Testing
- Baricitinib
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
Primary Biliary Cholangitis
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
- Trial name
- EPICS-IV (NCT07424677)
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Zydus Therapeutics Inc.
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
Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
Repeatability and Reproducibility of Quantitative MRCP
This study aims to determine the repeatability and reproducibility of Quantitative Magnetic Resonance Cholangiopancreatography (MRCP).
- Conditions
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Gallstones, Liver Diseases
- Trial name
- NCT03809559
- Testing
- MRCP+
- Where
- 2 sites in United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Perspectum
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
Primary Biliary Cholangitis, PBC
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible…
- Trial name
- VANTAGE (NCT05050136)
- Testing
- Volixibat
- Where
- 130 sites in United States, Argentina and 13 more
- Volunteers
- 333 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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.
Primary Biliary Cirrhosis
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
TQA3526 is a modified bile acid and 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
- NCT04278820
- Testing
- TQA3526
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Primary Biliary Cholangitis
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT06488911
- Testing
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Where
- 51 sites in United States, Argentina and 19 more
- Volunteers
- 62 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Liver Cirrhosis, Biliary
Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis
BCD-085 is an innovative drug, anti-interleukin-17 monoclonal antibody. The aim of the study is to evaluate the efficacy and safety of BCD-085 in patients with primary biliary cholangitis (PBC).
- Trial name
- NCT03476993
- Testing
- BCD-085
- Where
- 3 sites in Russia
- Volunteers
- 9 people
- Sponsor
- Biocad
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 Biliary Cholangitis
Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA).
- Trial name
- IDEAL (NCT06060665)
- Testing
- Seladelpar 10 mg
- Where
- 45 sites in United States, Canada
- Volunteers
- 96 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Trial name
- NCT03092765
- Testing
- E6011
- Where
- 46 sites in Japan
- Volunteers
- 29 people
- Sponsor
- EA Pharma Co., Ltd.
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
Primary Biliary Cholangitis
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
- Trial name
- EPICS-V (NCT07216235)
- Testing
- Saroglitazar magnesium 1 mg
- Where
- 3 sites in United States
- Volunteers
- 386 people
- Sponsor
- Zydus 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
Primary Biliary Cholangitis
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid…
- Trial name
- NCT03602560
- Testing
- seladelpar 5-10 mg, seladelpar 10 mg
- Where
- 156 sites in United States, Argentina and 21 more
- Volunteers
- 265 people
- Sponsor
- Gilead Sciences
Pruritus
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
- Trial name
- PACIFIC (NCT05525520)
- Testing
- EP547
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 62 people
- Sponsor
- Escient Pharmaceuticals, Inc