Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults

NCT04593784 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: AMAG-977-213
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily by an automated coagulometer device.

Conditions

Healthy

Keywords

ciraparantag; PER977; Apixaban; Rivaroxaban; Whole Blood Clotting Time (WBCT); Coagulometer; AMAG 977; Edoxaban

Outcome Measures

Primary Outcomes (1)

• Subjects Achieving WBCT ≤120% of Baseline

  The primary efficacy endpoint is achieving a WBCT (measured by PoC coagulometer) ≤ 120% of baseline within 1 hour after administration of ciraparantag/PBO, which is subsequently sustained after 1 hour through at least 6 hours after ciraparantag/PBO dosing (Responder).

  Within 1 hour and sustained through 6 hours

Study Arms (3)

Cohort 1

EXPERIMENTAL

Subjects receive 60 mg edoxaban orally once daily in the morning on Days 1 to 4. On Day 4, approximately 3 hours after administering edoxaban, study drug (ciraparantag or placebo) will be intravenously administered.

Drug: Ciraparantag; Drug: Placebo; Device: Point-of-Care Coagulometer (investigational device)

Cohort 2

EXPERIMENTAL

Subjects receive 10 mg apixaban orally every 12 hours on Days 1 to 3, with a final dose in the morning on Day 4. On Day 4, approximately 4 hours after administering apixaban, study drug (ciraparantag or placebo) will be intravenously administered.

Drug: Ciraparantag; Drug: Placebo; Device: Point-of-Care Coagulometer (investigational device)

Cohort 3

EXPERIMENTAL

Subjects receive 20 mg rivaroxaban orally once daily in the morning on Days 1 to 4. On Day 4, approximately 4 hours after administering rivaroxaban, study drug (ciraparantag or placebo) will be intravenously administered.

Drug: Ciraparantag; Drug: Placebo; Device: Point-of-Care Coagulometer (investigational device)

Interventions

Ciraparantag DRUG

Ciraparantag: 180 mg, intravenous

Also known as: PER977, AMAG 977

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Placebo: 0.9% sodium chloride, intravenous

Also known as: PBO

Cohort 1; Cohort 2; Cohort 3

Point-of-Care Coagulometer (investigational device) DEVICE

Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.

Also known as: Coagulometer

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• to 75 years of age.
• Be in generally good health
• BMI 18 to 32 kg/m2, inclusive, at Screening.
• If female, be surgically sterile or post-menopausal or if of child-bearing potential, using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1.
• If male, be surgically sterile, or agree to use appropriate contraception.
• Have suitable venous access for multiple venipunctures.

You may not qualify if:

• Have any of the following findings at Screening:
• Hemoglobin or hematocrit value outside the normal range
• Platelet count outside the normal range
• PT or aPTT outside the normal range
• Plasma fibrinogen outside the normal range
• Serum triglycerides or total cholesterol outside the normal range
• Serum creatinine \>1.5 mg/dL (133 μmol/L) or known renal disease
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 x the upper limit of normal, or known liver disease
• Total bilirubin outside the normal range
• Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• Positive pregnancy test (females)
• Positive drug, tobacco or alcohol screen
• Any clinically significant findings on 12-lead ECG or urinalysis
• Have a personal or family history of clotting disorder or hematologic abnormality.
• Have a history of unexplained syncope.

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead
• Ciraparantag Holdings GmbH: collaborator

Study Sites (3)

Qps-Mra, Llc.

South Miami, Florida, 33143, United States

Location

Frontage Clinical Services

Secaucus, New Jersey, 07094, United States

Location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

PER977

Results Point of Contact

• Title: Scientific Advisor
• Organization: Apollo Investment Management

rchari@kaiperheathcare.com

+352 2088 1301

Study Officials

• Advisor

  Apollo Investment Management

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Anticoagulant drugs will be administered in an open-label manner. Ciraparantag or placebo (PBO) will be administered in a double-blind manner. Subjects and all study site personnel except the study pharmacist will be blinded to individual subject treatment assignment (ciraparantag or PBO). The Sponsor will be unblinded to individual treatment assignments.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be conducted in separate cohorts; each cohort will evaluate the reversal of a different anticoagulant drug. Within each cohort, an initial group of subjects (Group 1) will be enrolled for evaluation of a target dose of ciraparantag. Depending on the efficacy and safety results from Group 1, a second group (Group 2) may be enrolled to evaluate a different dose of ciraparantag for that cohort.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: October 13, 2021
• Primary Completion: August 26, 2023
• Study Completion: August 26, 2023
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-03

Locations

US (3)