Trials / Completed
CompletedNCT03517540
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tropifexor (LJN452) | Comparison with monotherapy and different combination doses |
| DRUG | Cenicriviroc (CVC) | Comparison with monotherapy and different combination doses |
Timeline
- Start date
- 2018-09-11
- Primary completion
- 2020-09-15
- Completion
- 2020-10-15
- First posted
- 2018-05-07
- Last updated
- 2022-04-29
- Results posted
- 2021-11-12
Locations
65 sites across 17 countries: United States, Argentina, Belgium, Canada, Czechia, Egypt, France, Germany, India, Israel, Italy, Latvia, Russia, Singapore, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03517540. Inclusion in this directory is not an endorsement.