N/A N=119 Early Identification of Myocardial Impairment in PBC
Primary Biliary Cholangitis · Cardiovascular Abnormalities
Primary: The Incidence of Cardiac Events — 0; 0; 0; 0 Participants — p=0.001
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=217 Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Primary: DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo — 47; 10 percentage of participants — p=<0.0001
Phase 2 N=119 Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
Primary: Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8 — -26.06; -33.38; -41.42 percentage change from baseline — p== 0.2242
Phase 2 N=20 Pentoxifylline for Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Primary: Change in Serum Alkaline Phosphatase Levels. — -57.3 U/L — p=0.001
Phase 2 N=61 A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
Primary Biliary Cholangitis
Primary: Fold Change in Serum Gamma-glutamyl Transferase (GGT) — 0.74; 0.41; 0.28; 0.31 fold-change — p=0.293
Phase 3 N=193 RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Primary Biliary Cholangitis
Primary: Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤…
Phase 2 N=37 Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
Primary Biliary Cirrhosis
Primary: Effect of a 16-week Treatment Regimen of Saroglitazar Magnesium 2 mg and 4 mg on Alkaline Phosphatase (ALP) Levels in Patients With Primary Biliary Cholangitis…
Phase 2 N=77 Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis (PSC)
Primary: DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) — -105.05; -110.19; -26.76 U/L — p=0.0434
Phase 2 N=76 A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
Primary Biliary Cholangitis · Liver Stiffness
Primary: Change in ALP at Week 24 Compared to Baseline — 0.89; 0.84; 1.03 ratio — p=0.0206
Phase 2 N=45 Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cholangitis (PBC)
Primary: Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint) — -48.264; -40.640; 3.190 Percent change — p=<0.001
Phase 2 N=111 Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
Primary Biliary Cirrhosis
Primary: The Percent Change in Serum GGT. — -4.9; -19; -8.4 percent change
Phase 3 N=265 ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Primary Biliary Cholangitis
Primary: Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3…
Phase 2 N=27 Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Primary: Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration — -0.38 mmol/L
Phase 2 N=6 Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Primary: Number of Participants With Adverse Events — 1; 3; 2 Participants
Phase 2 N=60 Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
Liver Cirrhosis, Biliary
Primary: DB Phase: Mean Percent Change In Serum Alkaline Phosphatase (ALP) From Baseline To Day 85 — -44.5; -37.6; 0.4 Percent change — p=<0.0001
N/A N=4,577 Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
Primary Biliary Cholangitis
Primary: Risk of the First Event of the Composite Events — 8; 32 Events during the study period — p=<.001
Phase 2 N=62 Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Pruritus
Primary: Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6 — -2.20; -1.75 scores on a scale — p=0.4577
Phase 2 N=20 A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
Primary: Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12 — 0 participants
Phase 4 N=16 Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Primary: Biochemical Response — 1 Participants
Phase 2 N=24 Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
Primary Biliary Cholangitis · Primary Biliary Cirrhosis · Cholangitis
Primary: Percent Change in Alkaline Phosphatase (ALP) at Week 12 Compared to Baseline — -7.7 percent change — p==0.077
Phase 2 N=68 A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
Primary Biliary Cholangitis
Primary: Percentage of Participants With At Least a 20% Reduction in Alkaline Phosphatase (ALP) or Normalization of ALP at Week 12 Compared to Baseline — 45.2; 46.4; 11.1…
Phase 1 N=24 An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
Primary Biliary Cholangitis · Compensated Cirrhosis · Hepatic Impairment
Primary: Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3) — 182.0; 367.7; 359.2; 388.5 nanograms per milliliter (ng/mL)
Phase 2 N=121 Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
Primary: Number of Participants With Treatment Emergent Adverse Events — 21; 10; 16; 15 Participants
Phase 3 N=12 Betaine and Peroxisome Biogenesis Disorders
Peroxisome Biogenesis Disorders
Primary: Peroxisome Biochemical Functions as Measured by Plasma Very Long Chain Fatty Acid — 0.180; 0.188 ratio
Phase 2 N=24 PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Primary: Percentage Change From Baseline Through Week 24 in Serum Alkaline Phosphatase (ALP) — -4.5 percentage change in ALP
Phase 2 N=66 Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
PBC · Primary Biliary Cirrhosis
Primary: Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET) — 48.11; 52.10; 54.64; 49.46 units on a…
Phase 2 N=147 Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
Cholestasis
Primary: Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score — -1.73; -2.19; -2.60; -2.60 Scores on a scale
Phase 2 N=20 Use of Fenofibrate for Primary Biliary Cirrhosis
Primary Biliary Cirrhosis
Primary: Serum Level of Alkaline Phosphatase — 351; 175 U/L — p=<0.0001
Phase 2 N=40 APBI Proton Feasibility and Phase II Study
Stage IA-IIA Breast Cancer
Primary: Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons — 11; 0; 0; 0 Participants
Phase 2 N=10 Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.
Sclerosing Cholangitis
Primary: Adverse Event Frequency — 8 Participants