- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593784
Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ciraparantag for Reversal of Anticoagulation in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs (edoxaban, apixaban or rivaroxaban) in generally healthy adults. Throughout the study, coagulation status will be determined by whole blood clotting time (WBCT), which will be measured primarily by the Perosphere Technologies' PoC Coagulometer and at selected timepoints using a manual testing method.
The study will be conducted in three separate cohorts; each cohort will evaluate the reversal of a different anticoagulant drug. Within each cohort, an initial group of subjects (Group 1) will be enrolled for evaluation of a target dose of ciraparantag. Depending on the efficacy and safety results from Group 1, a second group (Group 2) may be enrolled to evaluate a different dose of ciraparantag for that cohort.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Trial Interest
- Phone Number: 1-877-374 -4177
- Email: CTInterest@covispharma.com
Study Locations
-
-
Florida
-
South Miami, Florida, United States, 33143
- Not yet recruiting
- Qps-Mra, Llc.
-
-
New Jersey
-
Secaucus, New Jersey, United States, 07094
- Recruiting
- Frontage Clinical Services
-
-
Texas
-
San Antonio, Texas, United States, 78209
- Not yet recruiting
- ICON Early Phase Services, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provide written informed consent.
- 18 to 75 years of age.
- Be in generally good health with BMI 18 to 32 kg/m2.
- If female, be surgically sterile or post-menopausal, or using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive).
- If male, be surgically sterile, or agree to use appropriate contraception.
- Have suitable venous access for multiple venipunctures.
Exclusion Criteria:
Have any of the following findings at Screening:
- Hemoglobin , hematocrit, platelets, PT, aPTT, fibrinogen, triglycerides, or bilirubin
- Serum creatinine >1.5 mg/dL or known renal disease
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x the upper limit of normal, or known liver disease
- Positive viral screen for HBV, HCV, or HIV
- Positive pregnancy test (females)
- Positive drug, tobacco or alcohol screen
- Any clinically significant findings on 12-lead ECG or urinalysis
- Have a personal or family history of clotting disorder or hematologic abnormality.
- Have a history of unexplained syncope.
- Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure, vaginal delivery, peptic ulcer or GI bleeding.
- Have received any blood product or anticoagulant, or donated any blood, within 3 months prior to Screening.
- Have a history of recurrent minor bleeding episodes.
- If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
- Have used any tobacco or nicotine-containing products within 3 months prior to Screening.
- Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1.
- If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
- Have received ciraparantag in any prior clinical study.
- Have received another investigational drug within 5 half-lives or 30 days, whichever is longer, prior to Day 1.
- Known allergy to apixaban or rivaroxaban.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
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.
|
Ciraparantag: 180 mg, intravenous
Other Names:
Placebo: 0.9% sodium chloride, intravenous
Other Names:
Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
Other Names:
|
Experimental: Cohort 2
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.
|
Ciraparantag: 180 mg, intravenous
Other Names:
Placebo: 0.9% sodium chloride, intravenous
Other Names:
Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
Other Names:
|
Experimental: Cohort 3
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.
|
Ciraparantag: 180 mg, intravenous
Other Names:
Placebo: 0.9% sodium chloride, intravenous
Other Names:
Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 6 Hours
|
6 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of subjects achieving WBCT ≤115% 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.
Time Frame: 6 Hours
|
6 Hours
|
|
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.
Time Frame: 6 Hours
|
6 Hours
|
|
The number of subjects achieving WBCT ≤120% of baseline within 30 minutes after administration of ciraparantag or placebo and sustained after 30 minutes through at least 6 hours after ciraparantag/placebo dosing.
Time Frame: 6 Hours
|
6 Hours
|
|
The number of subjects achieving WBCT ≤115% of baseline within 30 minutes after administration of ciraparantag or placebo and sustained after 30 minutes through at least 6 hours after ciraparantag/placebo dosing.
Time Frame: 6 Hours
|
6 Hours
|
|
The number of subjects achieving WBCT ≤110% of baseline within 30 minutes after administration of ciraparantag or placebo and sustained after 30 minutes through at least 6 hours after ciraparantag/placebo dosing.
Time Frame: 6 Hours
|
6 Hours
|
|
The number of subjects achieving WBCT ≤120% 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.
Time Frame: 6 Hours
|
6 Hours
|
|
The number of subjects achieving WBCT ≤115% 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.
Time Frame: 6 Hours
|
6 Hours
|
|
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.
Time Frame: 6 Hours
|
6 Hours
|
|
Correlation between WBCT measured with Perosphere Technologies' POC Coagulometer and with a manual testing method
Time Frame: 24 Hours
|
Correlation will be analyzed by a linear regression model.
|
24 Hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AMAG-977-213
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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