Status:
COMPLETED
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
Lead Sponsor:
Hepion Pharmaceuticals, Inc.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Fibrosis, Liver
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
Detailed Description
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects. Study will evaluate the safety and tolerability of a once daily 75mg dose ...
Eligibility Criteria
Inclusion
- Key
- Male or female between 18 and 75 years of age (inclusive).
- 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.
- Key
Exclusion
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- 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.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04480710
Start Date
June 23 2020
End Date
October 30 2021
Last Update
July 15 2022
Active Locations (10)
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1
Conquest Clinical Research
Orange, California, United States, 92866
2
Alliance Clinical Research
Poway, California, United States, 92064
3
La Salud Research, Inc.
Miami, Florida, United States, 33155
4
Progressive Medical Research
Port Orange, Florida, United States, 32127