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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593784
• Other study ID #: AMAG-977-213
• Status: Recruiting
• Phase: Phase 2
• Start date: October 13, 2021
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: AMAG Pharmaceuticals, Inc.
• Contact: Trial Interest
• Phone: 1-877-374 -4177
• Email: CTInterest[@]covispharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

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

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

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

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

5. Positive pregnancy test (females)

6. Positive drug, tobacco or alcohol screen

7. 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, vaginal delivery, peptic ulcer or GI bleeding.

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

6. Have a history of recurrent minor bleeding episodes.

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

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

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

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

11. Have received ciraparantag in any prior clinical study.

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

13. Known allergy to apixaban or rivaroxaban.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ciraparantag
Ciraparantag: 180 mg, intravenous
• Placebo
Placebo: 0.9% sodium chloride, intravenous

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

Locations

Country	Name	City	State
United States	ICON Early Phase Services, LLC	San Antonio	Texas
United States	Frontage Clinical Services	Secaucus	New Jersey
United States	Qps-Mra, Llc.	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlation between WBCT measured with Perosphere Technologies' POC Coagulometer and with a manual testing method	Correlation will be analyzed by a linear regression model.	24 Hours