At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
TNP-2092 capsules +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2a Study to Evaluate the Safety, Tolerability, PK Profile and Preliminary Efficacy of Multiple Doses of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia
In Brief
A Phase 2 clinical trial evaluating TNP-2092 capsules and Placebo for Hyperammonemia. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The aim of this study was to evaluate the safety, tolerability, and pharmacokinetic characteristics of TNP-2092 Capsules in liver cirrhosis patients with hyperammonemia; and to preliminarily observe the effects of the study drug on blood ammonia and hepatic encephalopathy related clinical symptoms and signs, neuropsychological indicators, and quality of life in liver cirrhosis patients with hyperammonemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperammonemia
CountriesChina
CollaboratorsThe First Hospital of Jilin University
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartAug 2020
Primary CompletionJun 2021
First PostedNov 2023
TodayJul 2026
First PostedNov 18, 2023
Enrollment StartAug 27, 2020
Primary CompletionJun 16, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.6 years ago
Interventions
TNP-2092 capsulesdrug
Administration orally.
Placebodrug
Administration orally.