Clinical trials: Intrahepatic Cholestasis
Primary Biliary Cirrhosis
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT01510860
- Testing
- UDCA (Ursodeoxycholic acid)
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Dr. Falk Pharma GmbH
Primary Biliary Cirrhosis
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis
The study is designed to evaluate the safety and efficacy of intravenous administration of bone marrow derived mesenchymal stem cells for patients with refractory primary biliary cirrhosis (PBC).
- Trial name
- MSCsTreatPBC (NCT01440309)
- Testing
- Biological: mesenchymal stem cell, ursodeoxycholic acid
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Robert Chunhua Zhao, MD, PhD
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- LEAP (NCT06193928)
- Testing
- Livmarli
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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 Cirrhosis
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
- Trial name
- CASCADE (NCT02321306)
- Testing
- LUM001
- Where
- 18 sites in United States, United Kingdom
- Sponsor
- Mirum Pharmaceuticals, Inc.
Autoimmune Liver Disease, Autoimmune Hepatitis
TruGraf Liver Gene Expression Serial Test
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months…
- Conditions
- Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- NCT06061341
- Testing
- TruGraf®
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Washington University School of Medicine
Progressive Familial Intrahepatic Cholestasis
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for…
- Trial name
- NCT04483531
- Testing
- Odevixibat
- Where
- United States
- Sponsor
- Albireo
Intrahepatic Cholestasis of Pregnancy
Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy
This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP.
- Trial name
- NCT06366659
- Where
- 2 sites in China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Peking University
Progressive Familial Intrahepatic Cholestasis
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
This study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) as they use odevixibat in their daily lives.
- Trial name
- NCT07185919
- Where
- 5 sites in South Korea
- Volunteers
- 10 people
- Sponsor
- Ipsen
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- MARCH-PFIC (NCT03905330)
- Testing
- Maralixibat
- Where
- 31 sites in United States, Argentina and 15 more
- Volunteers
- 93 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cirrhosis
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations.
- Trial name
- NCT02823353
- Testing
- Fenofibrate, UDCA
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cholangitis
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients.
- Trial name
- NCT05751967
- Testing
- Fenofibrate Combined With Ursodeoxycholic Acid
- Where
- 7 sites in China
- Volunteers
- 150 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Intrahepatic Cholestasis of Pregnancy
Il-17 Levels in Intrahepatic Cholestasis of Pregnancy
The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of…
- Trial name
- NCT01898832
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
PBC
Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression
Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestatic liver disease characterized by progressive, non-suppurative, destructive cholangitis, potentially leading to fibrosis, cirrhosis, and liver…
- Trial name
- NCT07733882
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Beijing Municipal Administration of Hospitals
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Biliary Atresia, Intrahepatic Cholestases
Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)
A prospective observational study in infants with biliary atresia and controls to determine whether the composition of the intestinal microbiome is specific for biliary atresia will be conducted.
- Conditions
- Biliary Atresia, Intrahepatic Cholestases, Normal Controls
- Trial name
- BA (NCT03890536)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC)
The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching
Cholestatic liver diseases are characterized by jaundice, pruritus, and elevated levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT).
- Conditions
- Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Atopic Dermatitis (AD)
- Trial name
- NCT07678645
- Testing
- Upadacitinib 15 MG
- Where
- China
- Volunteers
- 44 people
- Sponsor
- RenJi Hospital
Intrahepatic Cholestasis of Pregnancy
The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy
Intrahepatic cholestasis of pregnancy (ICP) is a unique disease of the liver resulting in abnormal bile acid levels and liver function. The incidence of ICP ranges from 0.1 - 15.6%.
- Trial name
- NCT01965054
- Testing
- Fish Oil Supplement Group
- Sponsor
- Icahn School of Medicine at Mount Sinai
Primary Biliary Cirrhosis
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
- Trial name
- PIANO (NCT01430429)
- Testing
- NI-0801
- Where
- 2 sites in Italy, United Kingdom
- Sponsor
- Light Chain Bioscience - Novimmune SA