Clinical trials: Biliary Cholestasis
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
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, Liver Stiffness
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to…
- Trial name
- TRANSFORM (NCT05014672)
- Testing
- Setanaxib
- Where
- 128 sites in United States, Australia and 16 more
- Volunteers
- 76 people
- Sponsor
- Calliditas Therapeutics Suisse SA
Primary Biliary Cirrhosis
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary…
- Trial name
- POISE (NCT01473524)
- Testing
- Obeticholic Acid (OCA)
- Where
- 59 sites in United States, Australia and 11 more
- Volunteers
- 217 people
- Sponsor
- Intercept Pharmaceuticals
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
Intrahepatic Cholestasis of Pregnancy
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat.
- Trial name
- OHANA (NCT04718961)
- Testing
- Volixibat
- Where
- 20 sites in United States, New Zealand and 1 more
- Volunteers
- 4 people
- Sponsor
- Mirum Pharmaceuticals, 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.
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 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 Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
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 Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
- Trial name
- PBC-Phase 2 (NCT02943447)
- Testing
- Cilofexor
- Where
- 25 sites in United States, Austria and 2 more
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences
PFIC1, PFIC2
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- PEDFIC 1 (NCT03566238)
- Testing
- A4250 (odevixibat)
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 62 people
- Sponsor
- Albireo
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
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
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 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
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
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