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

Last updated: April 4, 2025
Sponsor: AMAG Pharmaceuticals, Inc.
Overall Status: Terminated

Phase

2

Condition

N/A

Treatment

Point-of-Care Coagulometer (investigational device)

Ciraparantag

Placebo

Clinical Study ID

NCT04593784
AMAG-977-213
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provide written informed consent.

  2. 18 to 75 years of age.

  3. Be in generally good health

  4. BMI 18 to 32 kg/m2, inclusive, at Screening.

  5. If female, be surgically sterile or post-menopausal or if of child-bearingpotential, using an acceptable method of contraception (other than a combinationestrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1.

  6. If male, be surgically sterile, or agree to use appropriate contraception.

  7. Have suitable venous access for multiple venipunctures.

Exclusion

Exclusion Criteria:

  1. Have any of the following findings at Screening:

  2. Hemoglobin or hematocrit value outside the normal range

  3. Platelet count outside the normal range

  4. PT or aPTT outside the normal range

  5. Plasma fibrinogen outside the normal range

  6. Serum triglycerides or total cholesterol outside the normal range

  7. Serum creatinine >1.5 mg/dL (133 μmol/L) or known renal disease

  8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x theupper limit of normal, or known liver disease

  9. Total bilirubin outside the normal range

  10. Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV)

  11. Positive pregnancy test (females)

  12. Positive drug, tobacco or alcohol screen

  13. Any clinically significant findings on 12-lead ECG or urinalysis

  14. Have a personal or family history of clotting disorder or hematologic abnormality.

  15. Have a history of unexplained syncope.

  16. Have a history within 6 months prior to Screening of major bleeding, trauma,surgical procedure of any type, or vaginal delivery

  17. Have a history within 6 months prior to Screening of peptic ulcer orgastrointestinal bleeding.

  18. Have received any blood product or anticoagulant within 3 months prior to Screening.

  19. Have donated blood or blood products within 3 months prior to Screening

  20. Have a history of minor bleeding episodes within 1 month prior to Screening, or along-standing history of such bleeding.

  21. If female, have a history of excessive or dysfunctional uterine bleeding (unless thesubject had a subsequent hysterectomy).

  22. Have used any tobacco or nicotine-containing products within 3 months prior toScreening.

  23. Have used any systemic prescription or non-prescription drugs within 14 days priorto Day 1 (except for permitted contraceptives).

  24. If female, be pregnant, breastfeeding, or planning to become pregnant during thestudy.

  25. Have received ciraparantag in any prior clinical study.

  26. Have received another investigational drug within 5 half-lives or 30 days, whicheveris longer, prior to Day 1.

  27. Known allergy to edoxaban, apixaban or rivaroxaban.

  28. Have any other condition that, in the opinion of the Investigator, would interferewith a subject's ability to adhere to the protocol, interfere with assessment of theinvestigational product, or compromise the safety of the subject or the quality ofthe data.

Study Design

Total Participants: 41
Treatment Group(s): 3
Primary Treatment: Point-of-Care Coagulometer (investigational device)
Phase: 2
Study Start date:
October 13, 2021
Estimated Completion Date:
August 26, 2023

Study Description

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs (edoxaban, apixaban or rivaroxaban) in generally healthy adults. Throughout the study, coagulation status will be determined by whole blood clotting time (WBCT), which will be measured primarily by the Perosphere Technologies' PoC Coagulometer and at selected timepoints using a manual testing method.

The study will be conducted in three 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.

Connect with a study center

  • Qps-Mra, Llc.

    South Miami, Florida 33143
    United States

    Site Not Available

  • Frontage Clinical Services

    Secaucus, New Jersey 07094
    United States

    Site Not Available

  • ICON Early Phase Services, LLC

    San Antonio, Texas 78209
    United States

    Site Not Available

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