Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)
NCT06886360 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-03-20
Summary
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
Conditions
- Primary Sclerosing Cholangitis
Interventions
- DRUG
-
norucholic acid
500 mg norucholic acid film-coated tablets; 3 tablets/day
Sponsors & Collaborators
-
Dr. Falk Pharma GmbH
lead INDUSTRY
Principal Investigators
-
Michael Trauner, MD · Medical University of Vienna, dept. of Internal Medicine III
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
More Related Trials
-
Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis
NCT06865924 ·Status: RECRUITING ·Phase: NA
-
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
NCT04663308 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
NCT01688024 ·Status: UNKNOWN ·Phase: PHASE2
-
Pilot Study of FFP104 Dose Escalation in PBC Subjects
NCT02193360 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)
NCT05896137 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
NCT05450887 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
NCT04480840 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
NCT05627362 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
NCT04060147 ·Status: TERMINATED ·Phase: PHASE1
-
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
NCT04133792 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
NCT05912387 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
NCT03333928 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
NCT05642468 ·Status: TERMINATED ·Phase: PHASE2
-
Pilot Study of Fenofibrate for PSC
NCT01142323 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
NCT03890120 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
NCT07229911 ·Status: RECRUITING ·Phase: PHASE1
-
Trial of High-dose Urso in Primary Sclerosing Cholangitis
NCT00059202 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis
NCT03561584 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
NCT05104853 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)
NCT05896124 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
NCT03516006 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Primary Sclerosing Cholangitis in Children
NCT04181138 ·Status: RECRUITING
-
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
NCT00550862 ·Status: TERMINATED ·Phase: PHASE2
-
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
NCT00004842 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
NCT02308111 ·Status: TERMINATED ·Phase: PHASE4