NCT01951209 is a NA clinical trial of Rifaximin in Liver Cirrhosis, sponsored by David E. Kaplan, MD MSc.

Who is sponsoring NCT01951209?

NCT01951209 is sponsored by David E. Kaplan, MD MSc.

What drugs are being tested in NCT01951209?

Interventions in NCT01951209: Rifaximin, Placebo.

What condition does NCT01951209 study?

NCT01951209 studies Liver Cirrhosis, Chronic Hepatitis C.

Is NCT01951209 still recruiting?

NCT01951209 is currently terminated. Last updated 11 March 2021.

Last reviewed 2021-03-11 · How we verify

NCT01951209

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Study Of The Effect Of Rifaximin On B-Cell Dysregulation In Cirrhosis

Terminated NA Last updated 11 March 2021

What this trial tests

NA trial testing Rifaximin in Liver Cirrhosis in 13 participants. Terminated before completion.

Timeline

17 November 2016

Primary endpoint
17 November 2016

12 June 2017

Quick facts

Lead sponsor	David E. Kaplan, MD MSc
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	13
Start date	17 November 2016
Primary completion	17 November 2016
Estimated completion	12 June 2017
Sites	1 location across United States

Drugs / interventions tested

Rifaximin (rifaximin) — full drug profile →
Placebo

Conditions studied

Liver Cirrhosis — all drugs for Liver Cirrhosis →
Chronic Hepatitis C — all drugs for Chronic Hepatitis C →

Sponsor

David E. Kaplan, MD MSc

Who can join

Adults 18 to 70, any sex, with Liver Cirrhosis or Chronic Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatitis C is the leading cause of chronic liver disease and cirrhosis in United States veterans. Cirrhosis is associated with impaired antibody responses and increased risk of bacterial infections. We have recently identified that cirrhosis is associated with abnormalities of memory B-cells, cells that make antibodies and help protect against bacterial infections. We have identified that chemicals associated with gut bacteria might play a role in causing these B-cell abnormalities. It is well known that gut bacteria have increased access to the blood in individuals with cirrhosis, a process called bacterial translocation. We hypothesize that reducing bacteria counts in the gut by using poorly-absorbed antibiotics (also known as selective gut decontamination) will partially reverse losses of memory B-cells in cirrhosis by reducing bacterial translocation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.
Zacharias HD, Kamel F, Kamel F, Tan J, et al · · 2023 · cited 22× · PMID 37467180 · DOI 10.1002/14651858.cd011585.pub2

Verify or expand the search:

Other trials of Rifaximin

Trials testing the same drug.

NCT07209371 — Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance · Phase 2 · recruiting
NCT07203846 — Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor · Phase 4 · not yet recruiting
NCT06483737 — Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) · NA · recruiting
NCT06808009 — Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Re · NA · not yet recruiting
NCT06652087 — Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction · NA · recruiting

Other recruiting trials for Liver Cirrhosis

Currently open trials in the same condition.

NCT07439939 — Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Place · recruiting
NCT07325526 — A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- · Phase 2 · recruiting
NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
NCT07201649 — Roles of Hepatic Insufficiency, Hepatic Fibrosis, and Inorganic Pyrophosphate in the Progression of Arterial Calcificati · NA · recruiting
NCT07252102 — Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01951209 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by David E. Kaplan, MD MSc
Last refreshed: 11 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01951209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing