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Antibiotic

Rifamycin in Minimal Hepatic Encephalopathy (RIVET Trial)

Phase 2
Waitlist Available
Led By JASMOHAN BAJAJ
Research Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 37 days

Summary

This trial is testing whether a 600mg twice-daily dose of rifamycin SV-MMX, compared to placebo, is effective and safe in patients with cirrhosis.

Eligible Conditions
  • Hepatic Encephalopathy
  • Encephalopathy
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~37 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 37 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Liver Cirrhosis
Secondary study objectives
Rifamycins
Calprotectin levels in stool
EncephalApp Stroop OffTime+OnTime is the total time taken to complete 5 runs in Off and 5 runs in On state.
+12 more
Other study objectives
Body Muscle composition
Brain MR Spectroscopy in Anterior cingulate cortex, posterior gray matter, and right parietal white matter in a subset
Handgrip strength

Side effects data

From 2012 Phase 3 trial • 264 Patients • NCT01142089
9%
Headache
5%
Diarrhoea infectious
5%
Diarrhoea
4%
Constipation
2%
Dysmenorrhoea
1%
Dizziness
1%
Epistaxis
1%
Parasitic gastroenteritis
1%
Motion sickness
1%
Dysuria
1%
Nasopharyngitis
1%
Rhinorrhoea
1%
Urinary tract infection
1%
Dyspepsia
1%
Orthostatic hypotension
1%
Ligament sprain
1%
Somnolence
1%
Fatigue
1%
Muscle spasms
1%
Abdominal pain/vomiting
1%
Decreased appetite
1%
Muscle rupture
1%
Rash
1%
Insomnia
1%
Conjunctivitis
1%
Arthralgia
1%
Pharyngitis
1%
Neuroblastoma
1%
Pain
1%
Abdominal distension
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Rifamycin SV MMX

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RifamycinExperimental Treatment1 Intervention
Rifamycin-SV MMX 600 mg PO two times a day (1200 mg) for 30 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo PO two times a day for 30 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifamycin SV MMX
2019
Completed Phase 3
~300

Find a Location

Who is running the clinical trial?

Hunter Holmes Mcguire Veteran Affairs Medical CenterLead Sponsor
36 Previous Clinical Trials
21,556 Total Patients Enrolled
8 Trials studying Hepatic Encephalopathy
232 Patients Enrolled for Hepatic Encephalopathy
JASMOHAN BAJAJPrincipal InvestigatorHunter Holmes McGuire Medical Center
~5 spots leftby Jan 2026
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