CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

Primary Biliary Cholangitis (PBC) Clinical Trial

Official title:
A Phase II Study to Evaluate Safety, Tolerability and Efficacy, of CS0159 in Patients Subjects With PBC (Primary Biliary Cholangitis), Multicenter, Randomized 12-week, Double-blind, Placebo-controlled, and 40-weeks Open Study

Status Recruiting

Clinical Trial Summary

A phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis).

Clinical Trial Description

This is a phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis). The study has been designed to have two parts, the first part of the study will be double-blinded for 12 weeks. The second part of the study will be an open-label trail lasting 40 weeks. ;

Study Design

Related Conditions & MeSH terms

Cholangitis
Liver Cirrhosis, Biliary
Primary Biliary Cholangitis (PBC)

Clinical Trial Details

NCT number	NCT05896124
Study type	Interventional
Source	Cascade Pharmaceuticals, Inc
Contact	Rong Deng
Phone	+86-021-68030121
Email	dengrong@cascadepharm.com
Status	Recruiting
Phase	Phase 2
Start date	August 7, 2023
Completion date	October 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03188146` - Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
Not yet recruiting	`NCT03521297` - Probiotics in PBC Patients of Poor Response to UDCA	Phase 2
Recruiting	`NCT06016842` - A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis	Phase 3
Completed	`NCT04047160` - Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)	Phase 1
Completed	`NCT03124108` - Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid	Phase 2