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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04593784

Run by

AMAG Pharmaceuticals, Inc.

People needed

41

Starts

2021-10-13

Expected to finish

2023-08-26

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide written informed consent.
• 18 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.
• Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure of any type, or vaginal delivery
• Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding.
• Have received any blood product or anticoagulant within 3 months prior to Screening.
• Have donated blood or blood products within 3 months prior to Screening
• Have a history of minor bleeding episodes within 1 month prior to Screening, or a long-standing history of such bleeding.
• If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
• Have used any tobacco or nicotine-containing products within 3 months prior to Screening.
• Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1 (except for permitted contraceptives).
• If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
• Have received ciraparantag in any prior clinical study.

Where it is running

• Qps-Mra, Llc. — South Miami, Florida, United States
• Frontage Clinical Services — Secaucus, New Jersey, United States
• ICON Early Phase Services, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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