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Antibiotic

Rifamycin SV MMX for 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
Awards & highlights

RIVET Trial 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
  • Encephalopathy
  • Liver Cirrhosis

RIVET Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Liver Cirrhosis
Secondary outcome measures
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 outcome measures
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%
Dysuria
1%
Abdominal distension
1%
Rash
1%
Parasitic gastroenteritis
1%
Rhinorrhoea
1%
Muscle spasms
1%
Pharyngitis
1%
Neuroblastoma
1%
Abdominal pain/vomiting
1%
Decreased appetite
1%
Dizziness
1%
Conjunctivitis
1%
Insomnia
1%
Epistaxis
1%
Motion sickness
1%
Orthostatic hypotension
1%
Arthralgia
1%
Bronchitis
1%
Nasopharyngitis
1%
Ligament sprain
1%
Urinary tract infection
1%
Somnolence
1%
Fatigue
1%
Pain
1%
Muscle rupture
1%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Rifamycin SV MMX

RIVET 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
35 Previous Clinical Trials
21,521 Total Patients Enrolled
JASMOHAN BAJAJPrincipal InvestigatorHunter Holmes McGuire Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025