NCT04055389

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

August 7, 2019

Last Update Submit

February 23, 2022

Conditions

Portal Vein ThrombosisCirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Development of PVT

    incident of PVT measured by ultrasound at different time points

    up to 72 weeks

Study Arms (2)

AT-III treatment

EXPERIMENTAL
Drug: Antithrombin III

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Antithrombin IIIDRUG

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.

AT-III treatment
PlaceboOTHER

No study drug

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Antithrombin III

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antithrombin ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsAlpha-GlobulinsSerum GlobulinsBlood ProteinsProteinsGlobulinsBlood Coagulation Factor InhibitorsBiological Factors
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor Medicine

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 13, 2019

Study Start

January 1, 2021

Primary Completion

February 22, 2022

Study Completion

February 22, 2022

Last Updated

March 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)