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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to apixaban or rivaroxaban.You have a history of frequent small episodes of bleeding.You or someone in your family has a history of blood clotting problems or issues with your blood cells.You provide written informed consent.You are between the ages of 18 and 75.You have a history of fainting without a clear reason.You have taken ciraparantag in a previous research study.You are a male and you are not surgically sterile.You have used any tobacco or nicotine products in the last 3 months before the screening.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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