Clinical Trial Details
| Trial ID: | L0359 |
| Source ID: | NCT02960204 |
| Associated Drug: | Emricasan |
| Title: | Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension |
| Acronym: | ENCORE-PH |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT02960204/results |
| Conditions: | Cirrhosis|Portal Hypertension|Non-alcoholic Steatohepatitis |
| Interventions: | Drug: Emricasan|Drug: Placebo |
| Outcome Measures: | Mean Change in Hepatic Venous Pressure Gradient (HVPG)|Improvement of HVPG Response Using a 20% Reduction From Baseline|Caspase 3/7|Alanine Aminotransferase (ALT) |
| Sponsor/Collaborators: | Histogen |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 263 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | October 17, 2016 |
| Completion Date: | April 8, 2019 |
| Results First Posted: | January 14, 2022 |
| Last Update Posted: | February 11, 2022 |
| Locations: | Pasadena, Pasadena, California, United States|Rialto, Rialto, California, United States|Palmetto Bay, Palmetto Bay, Florida, United States|Atlanta, Atlanta, Georgia, United States|Clive, Clive, Iowa, United States|Baltimore, Baltimore, Maryland, United States|Detroit, Detroit, Michigan, United States|Rochester, Rochester, Minnesota, United States|Saint Paul, Saint Paul, Minnesota, United States|Kansas City, Kansas City, Missouri, United States|Durham, Durham, North Carolina, United States|Philadelphia, Philadelphia, Pennsylvania, United States|Philadelphia, Philadelphia, Pennsylvania, United States|Germantown, Germantown, Tennessee, United States|Arlington, Arlington, Texas, United States|Houston, Houston, Texas, United States|San Antonio, San Antonio, Texas, United States|San Antonio, San Antonio, Texas, United States|Norfolk, Norfolk, Virginia, United States|Richmond, Richmond, Virginia, United States|Richmond, Richmond, Virginia, United States|Seattle, Washington, Seattle, Washington, United States|Bonn, Bonn, Germany|Halle (Saale), Halle (Saale), Germany|Leipzig, Leipzig, Germany|Mainz, Mainz, Germany|M??nster, M??nster, Germany|Barcelona, Barcelona, Spain|Barcelona, Barcelona, Spain|Madrid, Madrid, Spain|Madrid, Madrid, Spain|Madrid, Madrid, Spain|Majadahonda, Majadahonda, Spain|San Sebastian, San Sebastian, Spain|Santander, Santander, Spain|Valencia, Valencia, Spain|Valencia, Valencia, Spain |
| URL: | https://ClinicalTrials.gov/show/NCT02960204 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D123 | Emricasan | Chemical drug | DB05408 | caspase inhibitor | Anti-inflammatory | Failed in clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D199 | L-alanine | Chemical drug | DB00160 | KYNU | -- | Failed in clinical trials | Details |