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Antibiotic

Rifaximin Arm for Hepatitis C (Rifaximin Trial)

Phase 2
Waitlist Available
Led By Elizabeth Verna, MD
Research Sponsored by Columbia University
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 one year post liver transplant
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

The purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver. Approximately 60 subjects will participate in this study. Subjects will be part of the study for approximately 1 year post transplant.

Eligible Conditions
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post liver transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post liver transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Significant recurrence of Hepatitis C
Secondary study objectives
Measurement of Serum LPS
Measurement of mRNA markers of the fibrosis cascade
Number of adverse events (severe and non-serious)

Side effects data

From 2014 Phase 4 trial • 222 Patients • NCT01842581
19%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Hyperkalaemia
2%
Bronchitis
2%
Peritonitis bacterial
2%
Liver transplant
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Non-cardiac chest pain
1%
Pneumonia
1%
Sepsis
1%
Fluid overload
1%
Hyperglycaemia
1%
Acute respiratory failure
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rifaximin ArmExperimental Treatment1 Intervention
Rifaximin will be initiated post-LT, once the subject is able to tolerate oral medications/diet. Rifaximin will be dosed at 550mg twice daily for 90 days (+/- 10 days) post-LT.
Group II: Placebo Control ArmPlacebo Group1 Intervention
Rifaximin placebo will be initiated post-LT, once the subject is able to tolerate oral medications/diet. Rifaximin placebo will be taken twice daily for 90 days (+/- 10 days) post-LT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
FDA approved

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,272 Total Patients Enrolled
7 Trials studying Hepatitis C
2,008 Patients Enrolled for Hepatitis C
Elizabeth Verna, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
8 Total Patients Enrolled
~4 spots leftby Nov 2025
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