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

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Portal Vein Thrombosis, Cirrhosis, Liver

In brief

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

Key facts

Study ID

NCT04055389

Run by

Jonathan Stine

People needed

0

Starts

2021-01-01

Expected to finish

2022-02-22

Last updated by the study team

2022-03-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cirrhosis documented by:
• Liver biopsy OR
• Clinical, imaging, and laboratory findings consistent with cirrhosis AND
• Disease process etiologic for cirrhosis (e.g., chronic viral hepatitis, non-alcoholic steatohepatitis, history of alcohol abuse, cholestatic liver disease)
• Flow in main portal vein less than 15 cm/sec or reversal of flow as assessed by Doppler ultrasonography
• Age greater than or equal to 18 and less than or equal to 75 years
• AT-III <70%
• Platelet count greater than or equal to 55,000 per uL
• Laboratories reflective of general health status (normal):
• White blood cell count (4-10.4 K/uL)
• Hemoglobin (11.7-15.0 g/dL) and hematocrit (35-44%)
• Creatinine (0.60-1.00 mg/dL) • Child Pugh Turcotte (CPT) Class A cirrhosis
• 2 Exclusion Criteria
• Allergy to AT-III or one of its ingredients
• CPT Class B or C cirrhosis
• Coagulopathy as indicated by International Normalized Ratio (INR) >= 2.2 or an inherited coagulation disorder
• Active hepatitis C infection expecting to initiate HCV therapy within the next two years
• Established PVT or cavernoma
• Transvenous portosystemic shunt (TIPS) placement
• Previous liver transplantation
• Increased risk of bleeding:
• Active pathological bleeding including subjects with actively bleeding esophageal varices
• History of intracranial bleeding
• Unexplained gastrointestinal bleeding
• Subjects with large esophageal varices, or varices with endoscopic stigmata of bleeding (e.g., red wale sign)

Where it is running

• Penn State College of Medicine — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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