A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Patients will received VS-01 intraperitoneally up to four consecutive days on top of SOC
Patients will received SOC
96 Jonathan Lucas St, CSB (Main Hospital), Suite 908
Charleston, South Carolina, United States
Nouvel Hôpital Civil, Service de Medecine Intensive Reanimation, 1, place de l'Hôpital
Strasbourg, France
Georgian Clinics" Kutaisi Referral Hospital 2, Otskheli str.
Kutaisi, Georgia
LEPL The First University Clinic of Tbilisi State, Medical University, Gudamakari str.4,,LEPL The First University Clinic
Time to improvement of OHE as assessed by HEGI
Time frame: from randomization and up to Day 5 morning
The incidence and severity ([NCI CTCAE] v5.0 grade) of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), comprising the evaluation of vital signs, ECG parameters, and laboratory parameters
\[NCI CTCAE\] v5.0 grade: National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: from randomization and up to Day 14 (more or less 3 days)
Pharmacokinetics (PD) (for all arms): change from Baseline (BL) in fasting blood and peritoneal fluid ammonia levels.
Time frame: from randomization up to Day 14 (more or less 3 days)
Pharmacokinetics (PK) (for active treatment arms): blood and peritoneal fluid concentration-time profile of baseline (BL) corrected citric acid and lipids in patients treated with VS-01.
Time frame: From randomization up to Day 5 or EOT (only for patients treated during 4 days)
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Tbilisi, Georgia
LLC Geo Hospitals Tbilisi, Multiprofile Medical Center, Tsinandali ,str. 9/3
Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva, High Medical Technology University Clinic, Tsinandali Street
Tbilisi, Georgia