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Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis

NCT04055389 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-03-10

No results posted yet for this study

Summary

To prevent portal vein thrombosis (PVT) in patients with cirrhosis at risk for PVT by pharmacologic prophylaxis with intravenous antithrombin (AT-III).

Conditions

  • Portal Vein Thrombosis
  • Cirrhosis, Liver

Interventions

DRUG

Antithrombin III

Patients with reversal of flow or sluggish flow in the main portal vein (\<15 cm/s by Doppler ultrasound exam) will be enrolled and randomized to either weekly infusions of AT-III (half-life \~4 days) at a weight-based dosage according to the following formula: \[Desired level of AT (100%) - Subject level of AT (%)\] \* subject weight (kg) 1.4 or placebo for 24 weeks of therapy.

OTHER

Placebo

No study drug

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • Jonathan Stine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-02-22
Completion
2022-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055389 on ClinicalTrials.gov