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Clinical study on the usefullness of edoxaban tosilate hydrate to portal vein thrombosis complicated with chronic liver disease

Clinical study on the usefullness of edoxaban tosilate hydrate to portal vein thrombosis complicated with chronic liver disease - PVTED study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030108
Enrollment
20
Registered
2017-11-24
Start date
2017-12-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal vein thrombosis

Interventions

Edoxaban 30 to 60 mg / day for 14 days

Sponsors

Kanazawa University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Clinically (histologically or imagewise) diagnosed as chronic liver disease. 2) Patients who have been confirmed to have thrombus in the portal vein, superior mesenteric vein, or / and splenic vein on the image. 3) The latest inspection value within 14 days before registration (same day as two weeks before the registration day is acceptable) satisfies all of the following. Hemoglobin 9.0 g / dl or more (male), 8.0 g / dl or more (female) Platelet count 50,000 / mm 3 or more Creatinine clearance 30 ml / min or more 4) Child-Pugh classification A or B. 5) Weight 40 kg or more. 6) About participation in the examination Informed consent is obtained from the patient himself.

Exclusion criteria

Exclusion criteria: 1. Child-Pugh classification C. 2. Endoscopic examination confirms the presence of lesions at risk of gastrointestinal bleeding (esophageal gastric varices, gastric / duodenal ulcers, gastric antral vascular dilation, etc.), and does not perform prophylactic treatment. 3. Have active malignancy. 4. Patients taking anticoagulant or / and antiplatelet drugs. 5. Patients with a history of clear bleeding symptoms such as cerebral haemorrhage. 6. Patients who weigh less than 40 kg at registration. 7. A woman who is pregnant or has a possibility of pregnancy, within 28 days after childbirth or breast-feeding. A man who wishes to become a partner's pregnant. 8. Mental illness or psychiatric symptoms are merged and it is judged that participation in the examination is difficult. 9. It has severe hypersensitivity to the ingredients of Edoxaban. 10. Because of drug allergy, neither CT nor MRI using a contrast agent can be performed. 11. Others, the doctor in charge determines that participation in this examination is inappropriate.

Design outcomes

Primary

MeasureTime frame
Reduction rate of portal vein thrombus 14 days after edoxaban administration

Secondary

MeasureTime frame
Safety of edoxaban administration against portal vein thrombosis

Countries

Japan

Contacts

Public ContactHajime Takatori

Kanazawa University Hospital Gastroenterology

takatori@m-kanazawa.jp076-265-2000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026