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Status unknownNCT03631147ERPVTUpdated Aug 15, 2018

The Effect of Rifaximin on Portal Vein Thrombosis

An interventional study of Rifaximin in Cirrhosis and Portal Vein Thrombosis, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-15.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

Portal vein thrombosis is not an uncommon complication in cirrhotic portal hypertension, which lead to a poor prognosis in endoscopic management of variceal bleeding. Evidence indicated that enoxaparin prevented PVT and liver decompensation via decreased rates of bacterial infections and lowered the potent inflammatory mediators such as interleukin-6. Rifaximin is a broad-spectrum antibiotic that exerts endotoxin-lowering and anti-inflammatory effects.

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Conditions studied

  • Cirrhosis
  • Portal Vein Thrombosis
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 96 is close to the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Rifaximin treatment group

    Rifaximin 400mg bid for 8 weeks

    Drug: Rifaximin

  • No intervention
    The control group

Interventions

  • DrugRifaximin

    400mg bid for 8 weeks

    Also known as: XIFAXAN

06

What researchers measure

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)

    Time frame: 8 weeks

Secondary 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)

    Time frame: 6 months

  2. All clinical events

    All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death

    Time frame: 8 weeks

  3. All clinical events

    All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death

    Time frame: 6 months

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Study locations

1 site
  • 180 Fenglin Road
    Shanghai, Shanghai 200032, China
08

References and documents

Publications

  • 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. PubMed 24686266 ↗
  • 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. PubMed 29720857 ↗
  • 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. PubMed 21216538 ↗
  • 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. PubMed 12939586 ↗
  • 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. PubMed 29735798 ↗
  • 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. PubMed 28671712 ↗
  • 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. PubMed 26618922 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03631147
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Shiyao Chen (Professor, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Aug 15, 2018
Start date
Sep 3, 2018 (estimated)
Primary completion
Jun 30, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Aug 15, 2018

Study contacts

Xiaoquan HUANG, M.D.
Contact
huangxiaoquan1010@aliyun.com
008618801733835
Shiyao CHEN, M.D.& Ph.D
Contact
chen.shiyao@zs-hospital.sh.cn

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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