Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT
NCT03172910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2025-09-02
Summary
This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban measuring clotting times using Whole Blood Clotting Time (WBCT).
Conditions
- Healthy
Interventions
- DRUG
-
Ciraparantag
Ciraparantag (administered over 10 minutes)
- DRUG
-
Saline for injection
- DRUG
-
Rivaroxaban
Rivaroxaban 20 mg given once per day (QD) in the morning
Sponsors & Collaborators
-
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-08
- Primary Completion
- 2019-11-12
- Completion
- 2019-11-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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