A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
NCT ID: NCT04480710
Last Updated: 2022-07-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2020-06-23
2021-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
NCT04134091
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
NCT05737433
6-week Safety and PD Study in Adults With NAFLD
NCT03256526
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
NCT04697810
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
NCT04857606
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CRV431 75mg
CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions
CRV431 75mg
1 x 75mg softgel capsule
Placebo, 75mg
Placebo, softgel capsule, QD, 28 days, fasted conditions
Placebo (1 softgel)
1 x placebo softgel capsule
CRV431 225mg
CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions
CRV431 225mg
3 x 75mg softgel capsule
Placebo, 225mg
CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions
Placebo (3 softgels)
3 x placebo softgel capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CRV431 75mg
1 x 75mg softgel capsule
Placebo (1 softgel)
1 x placebo softgel capsule
CRV431 225mg
3 x 75mg softgel capsule
Placebo (3 softgels)
3 x placebo softgel capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.
* Presumed F2/F3 NASH to include: AST \>20 IU/L, Pro-C3 \>15.5 ng/mL, enhanced liver fibrosis (ELF) score \>9.8, and FibroScan \>8.5 kPa values.
Exclusion Criteria
* Known allergy to CRV431, cyclosporine, or any of their inactive ingredients.
* Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus antibodies (HIVAb).
* Well documented causes of chronic liver disease according to standard diagnostic procedures to include any history or presence of decompensated cirrhosis.
* Subjects with a platelet count \<150,000/mL.
* Subjects with hemoglobin A1c(HbA1c) \>9.5%.
* Weight loss of more than 5% within 3 months prior to randomization.
* Subjects with a blood pressure to include a systolic pressure \>150 or a diastolic pressure \>90.
* At Screening, an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 mL (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] method) and/or a Kidney Disease Improving Global Outcomes (KDIGO) category of \>G2.
* Subjects with a history of organ transplantation. Corneal transplantation will be allowed.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hepion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlos Canizares, R.Ph.
Role: STUDY_DIRECTOR
Hepion Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Conquest Clinical Research
Orange, California, United States
Alliance Clinical Research
Poway, California, United States
La Salud Research, Inc.
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Covenant Research, LLC.
Sarasota, Florida, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Quality Research Inc.
San Antonio, Texas, United States
Pinnacle Research Group
San Antonio, Texas, United States
FDI Clinical Research
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HEPA-CRV431-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.