Clinical trials: Cholestasis, active
Cholestatic Liver Disease, Chronic Liver Disease (CLD)
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
The goal of this clinical trial is to learn whether adding calcitriol to vitamin D2 can improve vitamin D deficiency in children with cholestasis and chronic liver disease.
- Conditions
- Cholestatic Liver Disease, Chronic Liver Disease (CLD), Vitamin D Deficiency, Children
- Trial name
- VITD-CHOL (NCT07670611)
- Testing
- Vitamin D2, Calcitriol
- Where
- Thailand
- Volunteers
- 54 people
- Sponsor
- Chulalongkorn University
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.
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
Chronic Cholestasis, Severe Malnutrition
Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy
The goal of this clinical trial is to learn if a high-energy liquid diet improves the nutritional status of children with chronic cholestasis (a liver condition that blocks bile flow).
- Conditions
- Chronic Cholestasis, Severe Malnutrition, Pediatric Cholestasis
- Trial name
- NCT07569003
- Testing
- Nutrition Therapy
- Where
- Indonesia
- Volunteers
- 15 people
- Sponsor
- Universitas Indonesia
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
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
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
Cholestatic Liver Disease, Intrahepatic Cholestasis
Genotype-phenotype Relationship Between Cryptogenic Cholestasis and Familial Intrahepatic Cholestasis
Genotype-phenotype relationship between adult cryptogenic cholestasis and mutations in genes responsible for progressive familial intrahepatic cholestasis
- Conditions
- Cholestatic Liver Disease, Intrahepatic Cholestasis, Progressive Familial Intrahepatic Cholestasis, Hepatobiliary Cancer
- Trial name
- NCT06781242
- Where
- 2 sites in Italy
- Volunteers
- 300 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Primary Biliary Cholangitis, Liver Fibrosis
Patients With Primary Biliary Cholangitis(PBC)
Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced…
- Conditions
- Primary Biliary Cholangitis, Liver Fibrosis, Cirrhosis, Liver, Blood Sugar; High
- Trial name
- GLYPP (NCT07629128)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Primary Biliary Cholangitis
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT06365424
- Testing
- Fenofibrate, UDCA
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Intrahepatic Cholestasis of Pregnancy
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the…
- Trial name
- BAPP (NCT07428226)
- Where
- Germany
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Jena University Hospital
PBC, Primary Biliary Cholangitis (PBC)
Epidemiology of PrImary Biliary Cholangitis in Spain
Primary biliary cholangitis (PBC) is a rare, long-term liver disease that can slowly damage the bile ducts, eventually leading to cirrhosis and, in some cases, the need for a liver transplant.
- Trial name
- EPIC-PBC (NCT07821463)
- Where
- Spain
- Volunteers
- 3,000 people
- Sponsor
- Fundacio Privada Mon Clinic Barcelona
Biliary Atresia
Biliary Atresia Study in Infants and Children
Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples…
- Trial name
- BASIC (NCT00345553)
- Where
- 16 sites in United States, Canada
- Volunteers
- 1,265 people
- Sponsor
- Arbor Research Collaborative for Health
Pruritus, Primary Biliary Cholangitis
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.
- Trial name
- NCT06733519
- Testing
- Nalmefene
- Volunteers
- 40 people
- Sponsor
- Tharimmune Inc
Alagille Syndrome
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS).
- Trial name
- ASSERT-EXT (NCT05035030)
- Testing
- Odevixibat
- Where
- 35 sites in United States, Belgium and 8 more
- Volunteers
- 62 people
- Sponsor
- Albireo, an Ipsen Company
Primary Biliary Cholangitis
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis.
- Trial name
- AFFIRM (NCT06051617)
- Testing
- Seladelpar
- Where
- 217 sites in United States, Argentina and 27 more
- Volunteers
- 402 people
- Sponsor
- Gilead Sciences
Primary Sclerosing Cholangitis (PSC)
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
- Trial name
- NCT06699121
- Testing
- LB-P8 low-dose, LB-P8 high-dose
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- LISCure Biosciences
Cirrhosis, Cirrhosis, Liver
Liver Cirrhosis Network Cohort Study
Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis.
- Conditions
- Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B
- Trial name
- LCN-C (NCT05740358)
- Where
- 14 sites in United States
- Volunteers
- 1,222 people
- Sponsor
- Northwestern University
Immune-Mediated Cholestasis
Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis
The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period.
- Trial name
- CHILURSO (NCT07378761)
- Testing
- UDCA (Ursodeoxycholic acid), Corticosteroids (Reference Treatment)
- Where
- 6 sites in France
- Volunteers
- 94 people
- Sponsor
- University Hospital, Montpellier