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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
ICON Early Phase Services, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

A friend suggested this to help me financially.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
2021. "Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04593784.
~31 spots leftby Apr 2025
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