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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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