NCT02991612

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

December 10, 2016

Last Update Submit

May 4, 2018

Conditions

CirrhosisEsophageal and Gastric VaricesGastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Incidence of all clinical adverse events

    The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks

    8 weeks

Secondary Outcomes (3)

  • Changes of portal vein thrombosis

    2 months

  • Changes of intestinal flora

    2 months

  • The changes of serum level of cytokines

    8 weeks

Study Arms (2)

Rifaximin Treatment Group

EXPERIMENTAL

Rifaximin 400mg bid for 2 months,

Drug: Rifaximin

Control Group

NO INTERVENTION

Receive routine endoscopic treatment without having rifaximin for 2 months

Interventions

RifaximinDRUG

Patients receive Rifaximin 400mg bid for 2 months

Also known as: XIFAXAN
Rifaximin Treatment Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • y.o. ≤age≤75 y.o.;
  • Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).

You may not qualify if:

  • age \<18 y.o. or age \> 75 y.o.;
  • Never had the variceal bleeding episode before;
  • Do not have endoscopic treatment;
  • Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);
  • Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
  • Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.
  • Acute variceal bleeding within 5 days.
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

  • Huang XQ, Ai YJ, Li F, Ye ST, Wang JH, Zhang R, Zhang W, Zhu YL, Chen SY. Impact of rifaximin on cirrhosis complications and gastric microbiota in patients with gastroesophageal variceal bleeding: A pilot randomized controlled trial. J Dig Dis. 2024 Aug;25(8):504-516. doi: 10.1111/1751-2980.13314.

    PMID: 39443081DERIVED

  • Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

    PMID: 37467180DERIVED

MeSH Terms

Conditions

FibrosisEsophageal and Gastric VaricesGastrointestinal Hemorrhage

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver DiseasesHemorrhage

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Shiyao CHEN, M.D.

    Zhongshan Hospital, Fudan University, Shanghai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2016

First Posted

December 13, 2016

Study Start

November 25, 2016

Primary Completion

December 22, 2017

Study Completion

February 28, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

CN(1)