Phase II/III clinical trial of L-105 in patients with hepatic encephalopathy

Phase 2

• Conditions: H.E.

• Registration Number: JPRN-jRCT2080222040
• Lead Sponsor: ASKA Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Diagnosed as hepatic cirrhosis. In addition, patients having portal-systemic shunt without hepatic cirrhosis are eligible.
-Hyperammonemia
-Grade I or II mental state of H.E. (Classification by Inuyama Symposium)

Exclusion Criteria

-A concurrent mental illness
-Acute hepatitis or in the acute exacerbation phase of chronic hepatitis
-Concurrent hepatocellular carcinoma. However, patients, who were locally treated with hepatectomy, radio-frequency ablation (RFA), transcatheter hepatic arterial embolization (TAE), or percutaneous ethanol injection therapy (PEIT) 4 weeks prior to the start of study medication, are eligible.
-Planning to receive new treatment for hepatocellular carcinoma during the study period
-Likely to undergo liver transplant within 6 months after enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy (Blood ammonia level, PSE index), and Safety