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Anticoagulant Reversal Agent

Ciraparantag for Reversal of Anticoagulation in Healthy Subjects

Phase 2
Recruiting
Research Sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial will test whether a new drug is effective and safe at reversing the effects of different types of blood thinners in healthy adults.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of subjects achieving WBCT ≤120% of baseline within 1 hour after administration of ciraparantag or placebo and sustained after 1 hour through at least 6 hours after ciraparantag/placebo dosing.
Secondary outcome measures
Correlation between WBCT measured with Perosphere Technologies' POC Coagulometer and with a manual testing method
The number of subjects achieving WBCT ≤110% of baseline within 1 hour after administration of ciraparantag or placebo and sustained after 1 hour through at least 6 hours after ciraparantag/placebo dosing.
The number of subjects achieving WBCT ≤110% of baseline within 15 minutes after administration of ciraparantag or placebo and sustained after 15 minutes through at least 6 hours after ciraparantag/placebo dosing.
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment3 Interventions
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.
Group II: Cohort 2Experimental Treatment3 Interventions
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.
Group III: Cohort 1Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Ciraparantag
2017
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Lead Sponsor
11 Previous Clinical Trials
417 Total Patients Enrolled

Media Library

Ciraparantag (Anticoagulant Reversal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04593784 — Phase 2
Healthy Subjects Research Study Groups: Cohort 1, Cohort 2, Cohort 3
Healthy Subjects Clinical Trial 2023: Ciraparantag Highlights & Side Effects. Trial Name: NCT04593784 — Phase 2
Ciraparantag (Anticoagulant Reversal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04593784 — Phase 2
Healthy Subjects Patient Testimony for trial: Trial Name: NCT04593784 — Phase 2
~30 spots leftby Jun 2025
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