Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy

NCT03700723 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: RSX-201
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding

Conditions

Coagulopathy

Outcome Measures

Primary Outcomes (2)

• Change in INR

  Measured as a ratio

  120 minutes

• Total incidence of all related SAEs

  Count of events

  7 days

Secondary Outcomes (12)

• Change in activated partial thromboplastin time (aPTT)

  72 hours

• Change in platelet count

  72 hours

• Change in hemoglobin

  72 hours

• Change in clotting function

  72 hours

• Volume of plasma to correct INR

  72 hours

Study Arms (2)

Resusix

EXPERIMENTAL

The experimental drug (Resusix) will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period.

Biological: Resusix

FP24 (Frozen Plasma)

ACTIVE COMPARATOR

The active comparator FP24 will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period.

Biological: FP24 (Frozen Plasma)

Interventions

Resusix BIOLOGICAL

spray-dried solvent/detergent treated plasma (blood product)

Resusix

FP24 (Frozen Plasma) BIOLOGICAL

plasma frozen within 24 hours of phlebotomy

FP24 (Frozen Plasma)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SBP 90-150 mm Hg
• acquired coagulopathy due to hepatic disease
• INR \>1.4
• Order for 1-4 units of plasma for active bleeding or prophylaxis for bleeding prior to surgery or invasive procedure
• Written informed consent
• MELD score: 25 or less (1st cohort), 35 or less (2nd cohort)

You may not qualify if:

• Pregnant women
• Incarcerated patients
• Life expectancy less than 72 hours
• Severe bleeding at time of enrollment
• HIV, sepsis, intracranial bleeding, congenital disorder, anti-phospholipid antibody syndrome or known lupus anticoagulant antibodies
• Receipt of plasma products, coagulation factor concentrates or anti-platelets within 3 days of enrollment
• Specific factor inhibitor activity or history of hypersensitivity to plasma-derived products
• Receipt of iv heparin within 24 hours of enrollment
• Use of a continuous infusion of an intravenous vasoactive medication
• Thrombocytopenia
• BMI greater than or equal to 40 kg/m2
• Participation in another clinical trial within 30 days of enrollment and received investigational product that may impact safety or efficacy of this study
• West Haven Hepatic Encephalopathy Grade 3 or 4 (cohort 1) and Grade 4 (cohort 2)

Sponsors & Collaborators

• Entegrion, Inc.: lead

Study Sites (3)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Michael Galiger

  Entegrion, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 9, 2018
• Study Start: December 14, 2018
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

US (3)