| Trial ID: | L0476 |
| Source ID: | EUCTR2018-003443-31-CZ
|
| Associated Drug: |
Norursodeoxycholic acid
|
| Title: |
Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH)
- Norursodeoxycholic acid vs. placebo in NASH
|
| Acronym: |
--
|
| Status: |
Authorised
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic steatohepatitis (NASH) <br>MedDRA version: 24.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Digestive System Diseases [C0
|
| Interventions: |
<br>Product Name: Norursodeoxycholic acid (NorUDCA)<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Norucholic acid<br>CAS Number: 9697-24-2<br>Current Sponsor code: norUDCA<br>Other descriptive name: NOR-URSODEOXYCHOLIC ACID, NCA<br>Concentration
|
| Outcome Measures: |
Main Objective: To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASH ;Secondary Objective: To study safety and tolerability (adverse events [AEs], laboratory parameters) of norUDCA;Primary end point(s): Resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis from baseline to EOT/withdrawal visit <br>AND/OR <br>Improvement of fibrosis, and no worsening of NAS from baseline to EOT/withdrawal visit <br>;Timepoint(s) of evaluation of this end point: week 72 (EOT)/withdrawal visitSecondary end point(s): ?€? Improvement of NASH and no worsening of fibrosis from baseline to EOT/withdrawal <br>?€? Change in NAS from baseline to EOT/withdrawal visit<br>?€? ALT = 0.8 ULN at EOT/withdrawal visit;Timepoint(s) of evaluation of this end point: week 72 (EOT)/withdrawal visit
|
| Sponsor/Collaborators: |
Dr. Falk Pharma GmbH
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
363
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: yes<br>Other specify
|
| Start Date: |
05/03/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
2 March 2022
|
| Locations: |
Portugal;Czechia;Greece;Spain;Ireland;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Georgia;Germany;Latvia;Netherlands
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003443-31
|
