N/A
N=343
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
NASH - Nonalcoholic Steatohepatitis · Cirrhosis · Portal Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03439189 ↗Enrolled (actual)
343
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Subjects With Matched Clinically Significant Portal Hypertension Based on Hepatic Venous Pressure Gradient (HVPG) and Methacetin Breath Test (MBT) — 190 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Methacetin Breath Test (Combination_product); Emricasan (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Meridian Bioscience, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Matched Clinically Significant Portal Hypertension Based on Hepatic Venous Pressure Gradient (HVPG) and Methacetin Breath Test (MBT) |
190 | — |
| SECONDARY Number of Matched Subjects With Significant Portal Hypertension (Defined as HVPG>=12mmHg) Based on HVPG and MBT |
182 | — |
Summary
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12 mmHg respectively, in patients with non-alcoholic steatohepatitis (NASH) during the course of treatment with Conatus's investigational product emricasan/placebo.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
- Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
- Compensated cirrhosis OR Decompensated cirrhosis with no more than 1 prior significant decompensating event.
- Severe portal hypertension defined as HVPG ≥12 mmHg
- Subjects who are on NSBB, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to Day 1
- Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
Exclusion Criteria
- Evidence of severe decompensation
- Severe hepatic impairment defined as a Child-Pugh score ≥10
- ALT >3 times upper limit of normal (ULN) or AST >5 times ULN during screening
- Estimated creatinine clearance 50 ng/mL
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of >500 msec
- History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
- Prior liver transplant
- Change in diabetes medications or vitamin E within 3 months of screening
- Uncontrolled diabetes mellitus (HbA1c >9%) within 3 months of screening
- Significant systemic or major illness other than liver disease
- HIV infection
- Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening
- If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
- Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 1
Data sourced from ClinicalTrials.gov (NCT03439189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.