Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
NCT04593784 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2026-04-20
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
Interventions
- DRUG
-
Ciraparantag
Ciraparantag: 180 mg, intravenous
- DRUG
-
Placebo: 0.9% sodium chloride, intravenous
- DEVICE
-
Point-of-Care Coagulometer (investigational device)
Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
Sponsors & Collaborators
-
Ciraparantag Holdings GmbH
collaborator UNKNOWN -
AMAG Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Advisor · Apollo Investment Management
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-13
- Primary Completion
- 2023-08-26
- Completion
- 2023-08-26
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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