TERMINATED

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

Conditions

Healthy ciraparantag PER977 Apixaban Rivaroxaban Whole Blood Clotting Time (WBCT)Coagulometer AMAG 977 Edoxaban

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-10-13

Study Completion:2023-08-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04593784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provide written informed consent. 2. 18 to 75 years of age. 3. Be in generally good health 4. BMI 18 to 32 kg/m2, inclusive, at Screening. 5. If female, be surgically sterile or post-menopausal or if of child-bearing potential, using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1. 6. If male, be surgically sterile, or agree to use appropriate contraception. 7. Have suitable venous access for multiple venipunctures.	1. Have any of the following findings at Screening: 1. Hemoglobin or hematocrit value outside the normal range 2. Platelet count outside the normal range 3. PT or aPTT outside the normal range 4. Plasma fibrinogen outside the normal range 5. Serum triglycerides or total cholesterol outside the normal range 6. Serum creatinine \>1.5 mg/dL (133 μmol/L) or known renal disease 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 x the upper limit of normal, or known liver disease 8. Total bilirubin outside the normal range 9. Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) 10. Positive pregnancy test (females) 11. Positive drug, tobacco or alcohol screen 12. Any clinically significant findings on 12-lead ECG or urinalysis 2. Have a personal or family history of clotting disorder or hematologic abnormality. 3. Have a history of unexplained syncope. 4. Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure of any type, or vaginal delivery 5. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding. 6. Have received any blood product or anticoagulant within 3 months prior to Screening. 7. Have donated blood or blood products within 3 months prior to Screening 8. Have a history of minor bleeding episodes within 1 month prior to Screening, or a long-standing history of such bleeding. 9. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy). 10. Have used any tobacco or nicotine-containing products within 3 months prior to Screening. 11. Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1 (except for permitted contraceptives). 12. If female, be pregnant, breastfeeding, or planning to become pregnant during the study. 13. Have received ciraparantag in any prior clinical study. 14. Have received another investigational drug within 5 half-lives or 30 days, whichever is longer, prior to Day 1. 15. Known allergy to edoxaban, apixaban or rivaroxaban. 16. Have any other condition that, in the opinion of the Investigator, would interfere with a subject's ability to adhere to the protocol, interfere with assessment of the investigational product, or compromise the safety of the subject or the quality of the data.

Inclusion Criteria

Exclusion Criteria

1. Provide written informed consent.
2. 18 to 75 years of age.
3. Be in generally good health
4. BMI 18 to 32 kg/m2, inclusive, at Screening.
5. If female, be surgically sterile or post-menopausal or if of child-bearing potential, using an acceptable method of contraception (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to Day 1.
6. If male, be surgically sterile, or agree to use appropriate contraception.
7. Have suitable venous access for multiple venipunctures.

1. Have any of the following findings at Screening:
1. Hemoglobin or hematocrit value outside the normal range
2. Platelet count outside the normal range
3. PT or aPTT outside the normal range
4. Plasma fibrinogen outside the normal range
5. Serum triglycerides or total cholesterol outside the normal range
6. Serum creatinine \>1.5 mg/dL (133 μmol/L) or known renal disease
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 x the upper limit of normal, or known liver disease
8. Total bilirubin outside the normal range
9. Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
10. Positive pregnancy test (females)
11. Positive drug, tobacco or alcohol screen
12. Any clinically significant findings on 12-lead ECG or urinalysis
2. Have a personal or family history of clotting disorder or hematologic abnormality.
3. Have a history of unexplained syncope.
4. Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure of any type, or vaginal delivery
5. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding.
6. Have received any blood product or anticoagulant within 3 months prior to Screening.
7. Have donated blood or blood products within 3 months prior to Screening
8. Have a history of minor bleeding episodes within 1 month prior to Screening, or a long-standing history of such bleeding.
9. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
10. Have used any tobacco or nicotine-containing products within 3 months prior to Screening.
11. Have used any systemic prescription or non-prescription drugs within 14 days prior to Day 1 (except for permitted contraceptives).
12. If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
13. Have received ciraparantag in any prior clinical study.
14. Have received another investigational drug within 5 half-lives or 30 days, whichever is longer, prior to Day 1.
15. Known allergy to edoxaban, apixaban or rivaroxaban.
16. Have any other condition that, in the opinion of the Investigator, would interfere with a subject's ability to adhere to the protocol, interfere with assessment of the investigational product, or compromise the safety of the subject or the quality of the data.

Contacts and Locations

Study Locations (Sites)

Qps-Mra, Llc.

South Miami, Florida, 33143

United States

Frontage Clinical Services

Secaucus, New Jersey, 07094

United States

ICON Early Phase Services, LLC

San Antonio, Texas, 78209

United States

Collaborators and Investigators

Sponsor: AMAG Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-13

Study Completion Date2023-08-26

Study Record Updates

Study Start Date2021-10-13

Study Completion Date2023-08-26

Terms related to this study

Keywords Provided by Researchers

ciraparantag
PER977
Apixaban
Rivaroxaban
Whole Blood Clotting Time (WBCT)
Coagulometer
AMAG 977
Edoxaban

Additional Relevant MeSH Terms

Healthy