Clinical trials: Intrahepatic Cholestasis
Biliary Cirrhosis, Primary
Family Studies in Primary Biliary Cirrhosis (PBC)
Primary biliary cirrhosis (PBC) is a chronic liver disease primarily affecting middle age women. It is characterized by immune-mediated damage to cells lining the tiny bile ducts within the liver.
- Trial name
- NCT00242125
- Where
- Canada
- Volunteers
- 3,000 people
- Sponsor
- University Health Network, Toronto
Primary Biliary Cirrhosis
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT01865812
- Testing
- Obeticholic Acid
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Intercept Pharmaceuticals
Progressive Familial Intrahepatic Cholestasis
Gastrostomy-Biliary Diversion: Innovative Management for Bile Canalicular Transport Disorders
Progressive familial intrahepatic cholestasis (PFIC) is a group of disorders that can present early in life with cholestasis and intractable pruritus.
- Trial name
- NCT04071197
- Testing
- Gastostomy-biliary tube, External biliary diversion, internal biliary diversion and nasobiliary tube
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- National Liver Institute, Egypt
Primary Biliary Cirrhosis
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.
- Trial name
- NCT01857284
- Testing
- Tauroursodeoxycholic Acid Capsules, Ursodeoxycholic Acid Capsules
- Where
- 25 sites in China
- Volunteers
- 216 people
- Sponsor
- Beijing Friendship Hospital
Intrahepatic Cholestasis of Pregnancy
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of…
- Trial name
- NCT04922580
- Where
- China
- Volunteers
- 700 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Liver Cirrhosis, Biliary
Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women
Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk.
- Trial name
- CBP-HOPE (NCT03630718)
- Testing
- Psychoeducational Intervention, Hypnosis intervention
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Biliary Cirrhosis
Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis
This disease is believed to be due to immune cells, cells which normally protect the body, but are now destroying the bile ducts in the liver. When the ducts are damaged, bile builds up in the liver and damages liver tissue.
- Trial name
- NCT00393185
- Testing
- Non-myeloablative Hematopoietic Stem Cell Transplantation
- Sponsor
- Richard Burt, MD
Intrahepatic Cholestasis of Pregnancy
MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP)
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in pregnant women with intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- OASIS (NCT07823127)
- Testing
- Maralixibat
- Volunteers
- 15 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome (ALGS)
A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)
The main aim of the study is to check if TAK-625 improves symptoms of Alagille Syndrome (ALGS), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time.
- Trial name
- NCT05543174
- Testing
- TAK-625
- Where
- 8 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Takeda
Hepatobiliary Diseases
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases.
- Trial name
- NCT01200082
- Where
- United States
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Primary Biliary Cholangitis
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives.
- Trial name
- RESCAT (NCT05919433)
- Where
- Spain
- Volunteers
- 500 people
- Sponsor
- Hospital Mutua de Terrassa
Primary Biliary Cholangitis (PBC), Primary Biliary Cholangitis
Biochemical Response and Clinical Outcomes in Patients With PBC
This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics…
- Trial name
- NCT07449793
- Testing
- Only observation
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- RenJi Hospital
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC
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
PBC, Primary Biliary Cholangitis
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
The German PBC Cohort is a multi-centric, observational (non-interventional) study with three parallel groups. The main objective of this observational study is to describe the course of Primary biliary cholangitis (PBC) in…
- Trial name
- PBC-Cohort (NCT04076527)
- Testing
- UDCA, Ocaliva
- Where
- 50 sites in Germany
- Volunteers
- 1,200 people
- Sponsor
- University of Leipzig
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Primary Biliary Cholangitis (PBC)
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment.
- Trial name
- NCT06591468
- Testing
- Prednisone, UDCA (Ursodeoxycholic acid)
- Where
- 2 sites in China
- Volunteers
- 244 people
- Sponsor
- Han Ying
Primary Biliary Cholangitis (PBC)
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment.
- Trial name
- NCT07296458
- Testing
- Fenofibrate, UDCA (Ursodeoxycholic acid)
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cirrhosis
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT03301506
- Testing
- Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
- Where
- 109 sites in United States, Argentina and 23 more
- Volunteers
- 340 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis
This phase I/II clinical trial evaluates human umbilical cord-derived mesenchymal stromal cell (hUC-MSC) injection in patients with primary biliary cholangitis (PBC).
- Trial name
- MSC-PBC-I/II (NCT07795151)
- Testing
- Standard background therapy, hUC-MSC Dose Level 1, hUC-MSC Dose Level 2
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Beijing 302 Hospital