NCT03631147

Brief Summary

The aim of this study is to evaluate the efficacy of rifaximin in the treatment of portal vein thrombosis in cirrhotic patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

August 12, 2018

Last Update Submit

August 12, 2018

Conditions

CirrhosisPortal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Changes of portal vein thrombosis

    The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)

    8 weeks

Secondary Outcomes (3)

  • Changes of portal vein thrombosis

    6 months

  • All clinical events

    8 weeks

  • All clinical events

    6 months

Study Arms (2)

Rifaximin treatment group

EXPERIMENTAL

Rifaximin 400mg bid for 8 weeks

Drug: Rifaximin

The control group

NO INTERVENTION

Interventions

RifaximinDRUG

400mg bid for 8 weeks

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 patients had CTA confirmed portal vein trombosis
  • D-dimer no more than five times the normal upper limit

You may not qualify if:

  • age \<18 y.o. or age \> 75 y.o.
  • had portal cavernoma
  • received anticoagulation treatment in the past 6 months
  • splenectomy
  • Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
  • Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.
  • Acute variceal bleeding within 5 days.
  • Use of other antibiotics in the past 2 weeks
  • Acute portal vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (7)

  • Qi X, Han G, Fan D. Management of portal vein thrombosis in liver cirrhosis. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):435-46. doi: 10.1038/nrgastro.2014.36. Epub 2014 Apr 1.

    PMID: 24686266BACKGROUND

  • Mantaka A, Augoustaki A, Kouroumalis EA, Samonakis DN. Portal vein thrombosis in cirrhosis: diagnosis, natural history, and therapeutic challenges. Ann Gastroenterol. 2018 May-Jun;31(3):315-329. doi: 10.20524/aog.2018.0245. Epub 2018 Mar 3.

    PMID: 29720857BACKGROUND

  • Qi X, Bai M, Yang Z, Yuan S, Zhang C, Han G, Fan D. Occlusive portal vein thrombosis as a new marker of decompensated cirrhosis. Med Hypotheses. 2011 Apr;76(4):522-6. doi: 10.1016/j.mehy.2010.12.007. Epub 2011 Jan 8.

    PMID: 21216538BACKGROUND

  • D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.

    PMID: 12939586BACKGROUND

  • Cruz-Ramon V, Chinchilla-Lopez P, Ramirez-Perez O, Aguilar-Olivos NE, Alva-Lopez LF, Fajardo-Ordonez E, Ponciano-Rodriguez G, Northup PG, Intagliata N, Caldwell SH, Qi X, Mendez-Sanchez N. Thrombosis of the Portal Venous System in Cirrhotic vs. Non-Cirrhotic Patients. Ann Hepatol. 2018 May-June;17(3):476-481. doi: 10.5604/01.3001.0011.7392. Epub 2018 Apr 9.

    PMID: 29735798BACKGROUND

  • Kimer N, Pedersen JS, Tavenier J, Christensen JE, Busk TM, Hobolth L, Krag A, Al-Soud WA, Mortensen MS, Sorensen SJ, Moller S, Bendtsen F; members of the CoRif study group. Rifaximin has minor effects on bacterial composition, inflammation, and bacterial translocation in cirrhosis: A randomized trial. J Gastroenterol Hepatol. 2018 Jan;33(1):307-314. doi: 10.1111/jgh.13852.

    PMID: 28671712BACKGROUND

  • Bajaj JS. Review article: potential mechanisms of action of rifaximin in the management of hepatic encephalopathy and other complications of cirrhosis. Aliment Pharmacol Ther. 2016 Jan;43 Suppl 1:11-26. doi: 10.1111/apt.13435.

    PMID: 26618922BACKGROUND

MeSH Terms

Conditions

Fibrosis

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Xiaoquan HUANG, M.D.

CONTACT

008618801733835huangxiaoquan1010@aliyun.com

Shiyao CHEN, M.D.& Ph.D

CONTACT

chen.shiyao@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 15, 2018

Study Start

September 3, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

CN(1)