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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222040

Enrollment

180

Registered

2013-03-14

Start date

2013-03-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H.E.

Interventions

investigational material(s) Generic name etc : L-105 INN of investigational material : rifaximin Therapeutic category code : 619 Other antibiotic preparations (including mixed antibiotic preparations)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Efficacy (Blood ammonia level, PSE index), and Safety	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026