Status:
WITHDRAWN
Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis
Lead Sponsor:
Jonathan Stine
Collaborating Sponsors:
Grifols Therapeutics LLC
Conditions:
Portal Vein Thrombosis
Cirrhosis, Liver
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
To prevent portal vein thrombosis (PVT) in patients with cirrhosis at risk for PVT by pharmacologic prophylaxis with intravenous antithrombin (AT-III).
Detailed Description
PVT is a common complication in patients with cirrhosis, affecting 10% to 25% of patients. PVT is a potentially life-threatening occurrence, complicating transplant candidacy and reducing five-year su...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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)
- Subjects with gastric or intestinal varices
- Subjects who are taking medicines that increase the risk of thrombosis (e.g. tamoxifen)
- Subjects with any clinically significant bleeding within the last one month
- Need for therapeutic anticoagulation for another indication
- Concurrent use of antiplatelet medications excluding aspirin 81 mg once daily as aspirin at this dosage does not increase bleeding when given concomitantly with AT-III
- Pregnancy or breastfeeding
- Recent major surgery within six weeks
- Inability or unwilling to give informed consent
- Hepatocellular carcinoma \[diagnosed by cross-sectional imaging, e.g., computed tomography (CT) or magnetic resonance imaging (MRI)\] or another active malignancy
- Predicted lifespan less than two years
- Severe concurrent disease threatening successful completion of the trial in the opinion of the study principle investigator
- Ongoing substance abuse as judged by the study principal investigator and confirmed by an eight-panel urine drug test at screening
- Significant alcohol consumption (20g/day for women and 30g/day for men)
- Human Immunodeficiency Virus infection
- Worsening liver function based on the two initial laboratory values used to establish baseline laboratory measurements (section 7.2.2 Monitoring and Intervention Plan for Drug-induced Liver Injury)
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04055389
Start Date
January 1 2021
End Date
February 22 2022
Last Update
March 10 2022
Active Locations (1)
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1
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033