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

• Sponsor: Entegrion, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03700723
• Collaborator: (none)
• Enrollment: 4
• Locations: 3
• Arms: 2
• Actual Duration (Months): 16
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coagulopathy	Biological: Resusix; Biological: FP24 (Frozen Plasma)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Single blind
• Primary Purpose: Treatment
• Official Title: Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
• Actual Study Start Date: Dec 14, 2018
• Actual Primary Completion Date: Apr 15, 2020
• Actual Study Completion Date: Apr 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resusix 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; spray-dried solvent/detergent treated plasma (blood product)
Active Comparator: FP24 (Frozen Plasma) 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); plasma frozen within 24 hours of phlebotomy

Outcome Measures

Primary Outcome Measures

1. Change in INR [120 minutes]

   Measured as a ratio

2. Total incidence of all related SAEs [7 days]

   Count of events

Secondary Outcome Measures

1. Change in activated partial thromboplastin time (aPTT) [72 hours]

   Measured in seconds

2. Change in platelet count [72 hours]

   Measured in x10.e3/uL

3. Change in hemoglobin [72 hours]

   Measured in g/L

4. Change in clotting function [72 hours]

   Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM)

5. Volume of plasma to correct INR [72 hours]

   Measured in mL

6. Time to INR reduction below 1.5 [72 hours]

   Measured in minutes

7. Volume of fluid (e.g., crystalloid, colloid, blood component) administered [72 hours]

   Measured in mL

8. Change in bleeding score in patients with active bleeding [120 minutes]

   Measured as excellent, good or poor

9. Thrombin generation [72 hours]

   Measured in nM

10. Serology for human immunodeficiency virus [95 days]

    Measured in IU/mL

11. Serology for hepatitis [95 days]

    Measured in IU/mL

12. Change in Sequential Organ Failure Assessment Score (SOFA) [96 hours]

    Measured as 0 to 4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85721
2	Washington University St. Louis	Saint Louis	Missouri	United States	63110
3	Carolinas Medical Center	Charlotte	North Carolina	United States	28203

Sponsors and Collaborators

• Entegrion, Inc.

Investigators

• Study Director: Michael Galiger, Entegrion, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Entegrion, Inc.
• ClinicalTrials.gov Identifier: NCT03700723
• Other Study ID Numbers: RSX-201
• First Posted: Oct 9, 2018
• Last Update Posted: Jan 7, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Jan 7, 2021