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Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults

Sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04593784
Collaborator
(none)
108
Enrollment
3
Locations
3
Arms
9
Anticipated Duration (Months)
36
Patients Per Site
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily by an automated coagulometer device.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ciraparantag
  • Drug: Placebo
  • Device: Point-of-Care Coagulometer (investigational device)
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
The study will be conducted in 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.The study will be conducted in 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.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Anticoagulant drugs will be administered in an open-label manner. Ciraparantag or placebo (PBO) will be administered in a double-blind manner. Subjects and all study site personnel except the study pharmacist will be blinded to individual subject treatment assignment (ciraparantag or PBO). The Sponsor will be unblinded to individual treatment assignments.
Primary Purpose:
Treatment
Official Title:
A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ciraparantag for Reversal of Anticoagulation in Healthy Adults
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Drug: Ciraparantag
Ciraparantag: 180 mg, intravenous
Other Names:
  • PER977
  • AMAG 977

    • Drug: Placebo
    Placebo: 0.9% sodium chloride, intravenous
    Other Names:
  • PBO

    • Device: Point-of-Care Coagulometer (investigational device)
    Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
    Other Names:
  • Coagulometer

    		•
    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.

    Drug: Ciraparantag
    Ciraparantag: 180 mg, intravenous
    Other Names:
  • PER977
  • AMAG 977

    • Drug: Placebo
    Placebo: 0.9% sodium chloride, intravenous
    Other Names:
  • PBO

    • Device: Point-of-Care Coagulometer (investigational device)
    Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
    Other Names:
  • Coagulometer

    		•
    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.

    Drug: Ciraparantag
    Ciraparantag: 180 mg, intravenous
    Other Names:
  • PER977
  • AMAG 977

    • Drug: Placebo
    Placebo: 0.9% sodium chloride, intravenous
    Other Names:
  • PBO

    • Device: Point-of-Care Coagulometer (investigational device)
    Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
    Other Names:
  • Coagulometer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [6 Hours]

    Secondary Outcome Measures

    1. 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. [6 Hours]

    2. 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. [6 Hours]

    3. 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. [6 Hours]

    4. 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. [6 Hours]

    5. 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. [6 Hours]

    6. 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. [6 Hours]

    7. 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. [6 Hours]

    8. 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 Hours]

    9. Correlation between WBCT measured with Perosphere Technologies' POC Coagulometer and with a manual testing method [24 Hours]

      Correlation will be analyzed by a linear regression model.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Provide written informed consent.

    2. 18 to 75 years of age.

    3. Be in generally good health with BMI 18 to 32 kg/m2.

    4. If female, be surgically sterile or post-menopausal, or using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive).

    5. If male, be surgically sterile, or agree to use appropriate contraception.

    6. Have suitable venous access for multiple venipunctures.

    Exclusion Criteria:

    1. Have any of the following findings at Screening:

    2. Hemoglobin , hematocrit, platelets, PT, aPTT, fibrinogen, triglycerides, or bilirubin

    3. Serum creatinine >1.5 mg/dL or known renal disease

    4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x the upper limit of normal, or known liver disease

    5. Positive viral screen for HBV, HCV, or HIV

    6. Positive pregnancy test (females)

    7. Positive drug, tobacco or alcohol screen

    8. Any clinically significant findings on 12-lead ECG or urinalysis

    9. Have a personal or family history of clotting disorder or hematologic abnormality.

    10. Have a history of unexplained syncope.

    11. Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure, vaginal delivery, peptic ulcer or GI bleeding.

    12. Have received any blood product or anticoagulant, or donated any blood, within 3 months prior to Screening.

    13. Have a history of recurrent minor bleeding episodes.

    14. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).

    15. Have used any tobacco or nicotine-containing products within 3 months prior to Screening.

    16. Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1.

    17. If female, be pregnant, breastfeeding, or planning to become pregnant during the study.

    18. Have received ciraparantag in any prior clinical study.

    19. Have received another investigational drug within 5 half-lives or 30 days, whichever is longer, prior to Day 1.

    20. Known allergy to apixaban or rivaroxaban.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qps-Mra, Llc. South Miami Florida United States 33143
    2 Frontage Clinical Services Secaucus New Jersey United States 07094
    3 ICON Early Phase Services, LLC San Antonio Texas United States 78209

    Sponsors and Collaborators

    • Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04593784
    Other Study ID Numbers:
    • AMAG-977-213
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
    ciraparantag
    PER977
    Apixaban
    Rivaroxaban
    Whole Blood Clotting Time (WBCT)
    Coagulometer
    AMAG 977
    Edoxaban

    Study Results

    No Results Posted as of Mar 7, 2022