Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia

Hyperammonemia Clinical Trial

Official title:
A Phase 1b/2a, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Multiple Ascending Doses of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06135675
Study type	Interventional
Source	TenNor Therapeutics Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 27, 2020
Completion date	June 12, 2021

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See also
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Completed	`NCT03947034` - Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
Completed	`NCT06178718` - A Phase 1, Single-center, Double-blind, Placebo-controlled Study of TNP-2092 Capsules, and the Food Effect Study After Single-dose Oral Administration of TNP-2092 Capsules	Phase 1
Recruiting	`NCT05040178` - An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics
Withdrawn	`NCT00279851` - Blood Sugars in Children With Idiopathic Seizures.