Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01842581 · ClinicalTrials.gov registry record · Phase 4
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
A Phase 4 study of Cirrhosis and Hepatic Encephalopathy, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 4
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT01842581: Completed Phase 4 study of Cirrhosis and Hepatic Encephalopathy, sponsored by Bausch Health Americas.
NCT01842581 is a Phase 4 study of Cirrhosis and Hepatic Encephalopathy that has completed, run by Bausch Health Americas. The registered enrollment target is 222 participants, below the 90,405-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01842581, a Phase 4 study of Cirrhosis and Hepatic Encephalopathy, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
Primary Outcome
A breakthrough HE episode was defined as an increase of the Conn score to Grade greater than or equal to (≥) 2 (ie, 0 or 1 to ≥ 2). Conn score is widely used as a measure of mental state in HE. The scale used in Conn scoring system include: Grade 0=No personality or behavioral abnormality; Grade 1=Trivial lack of awareness, euphoria, or anxiety; shortened attention span, impairment of addition or subtraction; Grade 2=Lethargy, disorientation for time, obvious personality change, inappropriate be
Conditions Studied
Interventions
- DRUG Rifaximin
- DRUG Lactulose
Study Locations (20)
California
- Southern California Liver Centers - Coronado
- UCSF/Fresno - CRMC - Fresno
- UCSD Clinical & Translational Research Institute - La Jolla
- Salix Site - Long Beach
- Inland Empire Liver Foundation - Rialto
- Salix Site - Riverside
- Salix Site - San Diego
- Salix Site - San Francisco
Colorado
- University of Colorado Denver - Aurora
- South Denver GI - Englewood
Florida
- University of Florida Hepatology - Gainesville
- Tampa General Medical Group - Tampa
Louisiana
- Salix Site - Jefferson
- Delta Research Partners, LLC - Monroe
Arizona
- Banner Research - Phoenix
Georgia
- Gastroenterology Associates - Macon
Illinois
- Salix Site - Chicago
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2014-12-17 |
| Phase | Phase 4 |
What the finished NCT01842581 record still lists
NCT01842581 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 90,405-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Rifaximin is the first listed.
NCT01842581 names 20 study sites across 10 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01842581 about?
NCT01842581 is a clinical study titled "The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy". The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
What is the current status of trial NCT01842581?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 222 participants. The study started on 2013-01-08. Estimated completion is 2014-12-17.
What conditions does trial NCT01842581 study?
This clinical trial studies the following conditions: Cirrhosis, Hepatic Encephalopathy.
What interventions are being tested in trial NCT01842581?
The interventions under investigation include: Rifaximin (DRUG), Lactulose (DRUG).
Who is sponsoring clinical trial NCT01842581?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01842581 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01842581's enrollment target sits among peer trials
222 12th of 53 higher than 42 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
COMPLETED · Phase 4
-
Ramelteon for Treatment of Insomnia in Cirrhosis
COMPLETED · Phase 4
-
Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting
RECRUITING
-
LiverSleep: A Behavioral Sleep Intervention for Patients With Cirrhosis and Insomnia
RECRUITING · NA
-
Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
RECRUITING · Phase 2
-
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04939610 · 222 participants · Phase 1
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
- NCT05424783 · 222 participants
MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)
- NCT05568264 · 222 participants · NA
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
- NCT05605574 · 222 participants · NA
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI