Clinical trials: Biliary Cirrhosis, Primary
Primary Biliary Cirrhosis
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases…
- Trial name
- NCT02659696
- Where
- Japan
- Volunteers
- 44 people
- Sponsor
- Teikyo University
Primary Biliary Cholangitis, Primary Sclerosing Cholangitis
The Effect of Bezafibrate on Cholestatic Itch
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
- Conditions
- Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
- Trial name
- FITCH (NCT02701166)
- Testing
- Bezafibrate
- Where
- 9 sites in Netherlands, Spain
- Volunteers
- 84 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Primary Biliary Cirrhosis
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
TQA3526 is a modified bile acid and FXR agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04278820
- Testing
- TQA3526
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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 Sclerosing Cholangitis, Compensated Cirrhosis
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
- Trial name
- NCT04060147
- Testing
- Cilofexor
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis, Compensated Cirrhosis
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.
- Trial name
- NCT06525311
- Testing
- K-808
- Where
- 10 sites in United States, Japan
- Volunteers
- 17 people
- Sponsor
- Kowa Research Institute, Inc.
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, Autoimmune Hepatitis
Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis
The purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.
- Trial name
- PBC (NCT00587119)
- Testing
- Budesonide
- Sponsor
- Mayo Clinic
Primary Biliary Cirrhosis
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
The primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, treatment is based in the use of ursodeoxycholic acid (UDCA) at a daily dose of 13 to 15 mg/kg, without other treatment options.
- Trial name
- NCT02937012
- Testing
- Bezafibrate, Ursodeoxycholic Acid
- Where
- Mexico
- Volunteers
- 34 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects.
- Conditions
- Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
- Trial name
- NCT02963077
- Testing
- A4250, CRC (A3384), Questran
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Albireo
Primary Biliary Cholangitis
Study of [14C]CS0159 in China Healthy Subjects
Study of [14C]CS0159 in China Healthy Subjects.
- Trial name
- NCT06098027
- Testing
- [14C]CS0159
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
BPC, Non Optimal Response to UDCA
Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy
Primary biliary cholangitis (PBC) is a rare chronic, progressive, cholestatic liver disease that leads to cirrhosis and its life-threatening complications if undertreated.
- Trial name
- BEZURSO 2 (NCT06443606)
- Testing
- Bezafibrate 400 mg in addition to UDCA therapy, Bezafibrate 200 mg in addition to UDCA therapy
- Where
- France
- Volunteers
- 108 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Biliary Cholangitis (PBC), Cirrhosis
PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.
Purpose The primary purpose is to use an imaging diagnostic method to examine how the medication for primary biliary cholangitis (PBC) works.
- Conditions
- Primary Biliary Cholangitis (PBC), Cirrhosis, Cholestasis, Ursodeoxycholic Acid
- Trial name
- NCT06604923
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- University of Aarhus
Primary Biliary Cholangitis (PBC)
Probiotics in PBC Patients of Poor Response to UDCA
The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.
- Trial name
- NCT03521297
- Testing
- Probiotic
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-sen University
Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.
- Trial name
- NCT04047160
- Testing
- OP-724
- Where
- 2 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Kiminori Kimura, MD
Cholestasis, Primary Sclerosing Cholangitis
Paternally Inherited Phenotypes in Cholestasis
For some years investigators have known that the health of fathers at the time their baby is conceived has an influence on the health of their child in the future.
- Conditions
- Cholestasis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- PIP-C (NCT03337074)
- Testing
- Questionnaire, semen sample, fasting blood sample, Questionnaire, Questionnaire, fasting blood sample
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
PBC
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis
This is a Phase III, randomized, double-blind, multicentre study assessing the efficacy and safety of obecholic acid and Ursodeoxycholic Acid(UDCA) compared with placebo and UDCA in treating of primary biliary cirrhosis (PBC) in…
- Trial name
- NCT06715319
- Testing
- OCA, UDCA
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Hepatitis, Autoimmune, Primary Biliary Cholangitis
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
- Trial name
- NCT04617561
- Testing
- Ursodeoxycholic acid, Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
- Where
- China
- Volunteers
- 90 people
- Sponsor
- West China Hospital
Primary Biliary Cirrhosis
Use of Fenofibrate for Primary Biliary Cirrhosis
This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
- Trial name
- NCT00575042
- Testing
- Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Primary Biliary Cirrhosis
Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a slowly progressive disease that causes substantial loss of intrahepatic bile ducts, ultimately resulting in cholestasis, advanced fibrosis, cirrhosis, liver failure and even hepatocellular…
- Trial name
- NCT01662973
- Testing
- conventional plus UC-MSC treatment
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Beijing 302 Hospital