NCT00748904

Brief Summary

The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

September 8, 2008

Last Update Submit

January 24, 2022

Conditions

Liver CirrhosisRenal Failure

Keywords

cirrhosis of liver and progressive renal failure

Outcome Measures

Primary Outcomes (1)

  • slower progression to severe hepatic encephalopathy, stage 3 or 4

    during hospitalization

Study Arms (2)

A

EXPERIMENTAL

35 patients receiving rifaximin

Drug: Rifaximin

B

EXPERIMENTAL

35 patients receiving lactulose

Drug: Lactulose

Interventions

RifaximinDRUG

400 mg orally

Also known as: Xifaxin, Salix Pharmaceuticals
A
LactuloseDRUG

20 grams titrate to 2-3 bowel movements in one day

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhosis of liver of any etiology
  • progressive renal failure
  • stage 0-2 hepatic encephalopathy

You may not qualify if:

  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Liver CirrhosisRenal InsufficiencyFibrosis

Interventions

RifaximinLactulose

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 8, 2022

Record last verified: 2022-01

Locations

US(1)