Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients with Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Treatment period NTZ 500mg BID on top of SOC
To evaluate the safety of 500 mg BID NTZ administered perorally
Safety defined as the incidence, relatedness, and severity (NCI-CTCAE v6.0 grade) of TEAEs including SAEs (comprising the evaluation of vital signs, ECGs, and laboratory parameters).
Time frame: over 7 days on top of SOC follow-up period up to Day 28.
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