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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

Summary

This trial tests ciraparantag, a medication that helps blood to clot normally by neutralizing the effects of blood thinners in generally healthy adults.

Who is the study for?
This trial is for generally healthy adults aged 18-75 with a BMI of 18 to 32 kg/m2. Men must be sterile or use contraception; women must be sterile, post-menopausal, or using non-hormonal contraception. Participants need good venous access and cannot have allergies to certain anticoagulants, bleeding disorders, severe kidney disease, recent major bleeding events or drug/alcohol/tobacco use.
What is being tested?
The study tests Ciraparantag's ability to reverse the effects of anticoagulants like Edoxaban, Apixaban or Rivaroxaban in healthy adults. It's randomized and placebo-controlled: some get Ciraparantag while others get a dummy pill (placebo), without knowing which one they receive.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to reversing blood thinning such as clotting issues. Since it involves stopping anticoagulation drugs' effects, there might also be risks associated with changes in blood coagulation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Correlation between WBCT measured with Perosphere Technologies' POC Coagulometer and with a manual testing method

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
Ciraparantag
2017
Completed Phase 2
~130
Placebo
1995
Completed Phase 3
~2670

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
~26 spots leftby Dec 2025