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Rifamycin in Minimal Hepatic Encephalopathy

NCT04082780 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-21

No results posted yet for this study

Summary

This is a randomized double-blind placebo-controlled trial of MHE in patients with cirrhosis using rifamycin SV-MMX 600mg BID vs placebo for 30 days with PK, safety, microbiota, brain function and brain MRI endpoints.

Conditions

  • Hepatic Encephalopathy
  • Cirrhosis, Liver

Interventions

DRUG

Rifamycin SV MMX

Intervention arm

OTHER

Placebo

Placebo arm

Sponsors & Collaborators

  • Hunter Holmes Mcguire Veteran Affairs Medical Center

    lead FED

Principal Investigators

  • JASMOHAN BAJAJ · Hunter Holmes McGuire Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-04-28
Completion
2023-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082780 on ClinicalTrials.gov