HealthyPhase 2NCT04593784
Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
A Phase 2 study testing Ciraparantag and Point-of-Care Coagulometer (investigational device) in people with Healthy, run by AMAG Pharmaceuticals, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ciraparantag and Point-of-Care Coagulometer (investigational device)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Oct 2021to 26 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- 18 to 75 years of age.
- Be in generally good health
- BMI 18 to 32 kg/m2, inclusive, at Screening.
- 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.
- If male, be surgically sterile, or agree to use appropriate contraception.
- Have suitable venous access for multiple venipunctures.
Who cannot join
- Have any of the following findings at Screening:
- Hemoglobin or hematocrit value outside the normal range
- Platelet count outside the normal range
- PT or aPTT outside the normal range
- Plasma fibrinogen outside the normal range
- Serum triglycerides or total cholesterol outside the normal range
Show all 28Show fewer
- Serum creatinine >1.5 mg/dL (133 μmol/L) or known renal disease
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x the upper limit of normal, or known liver disease
- Total bilirubin outside the normal range
- Positive viral screen for hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (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 of any type, or vaginal delivery
- Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding.
- Have received any blood product or anticoagulant within 3 months prior to Screening.
- Have donated blood or blood products within 3 months prior to Screening
- Have a history of minor bleeding episodes within 1 month prior to Screening, or a long-standing history of such bleeding.
- 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 (except for permitted contraceptives).
- 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 edoxaban, apixaban or rivaroxaban.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
Frontage Clinical Services
Secaucus, New Jersey, 07094
Qps-Mra, Llc.
South Miami, Florida, 33143
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ciraparantag, Placebo, Point-of-Care Coagulometer (investigational device)
- Keywords
- ciraparantag, PER977, Apixaban, Rivaroxaban, Whole Blood Clotting Time (WBCT), Coagulometer, AMAG 977, Edoxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiraparantagDrug
Also called PER977, AMAG 977
Ciraparantag: 180 mg, intravenous
PlaceboDrug
Also called PBO
Placebo: 0.9% sodium chloride, intravenous
Point-of-Care Coagulometer (investigational device)Device
Also called Coagulometer
Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Drug: Ciraparantag; Drug: Placebo; Device: Point-of-Care Coagulometer (investigational device) |
| Cohort 2 | Experimental | 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. Receives: Drug: Ciraparantag; Drug: Placebo; Device: Point-of-Care Coagulometer (investigational device) |
| Cohort 3 | Experimental | 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. Receives: Drug: Ciraparantag; Drug: Placebo; Device: Point-of-Care Coagulometer (investigational device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Achieving WBCT ≤120% of Baseline
The primary efficacy endpoint is achieving a WBCT (measured by PoC coagulometer) ≤ 120% of baseline within 1 hour after administration of ciraparantag/PBO, which is subsequently sustained after 1 hour through at least 6 hours after ciraparantag/PBO dosing (Responder).
Measured: Within 1 hour and sustained through 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start13 Oct 2021
- Primary completion26 Aug 2023
- Study completion26 Aug 2023
Why it stopped: Sponsor decision unrelated to safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ciraparantag Holdings GmbH
- Responsible party
- Sponsor
- Investigators
- Advisor, Study director, Apollo Investment Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593784
- Sponsor's protocol ID
- AMAG-977-213
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2020
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04593784
- Acronym / sponsor ID
- AMAG-977-213
- Conditions
- Healthy
- Keywords
- ciraparantag, PER977, Apixaban, Rivaroxaban, Whole Blood Clotting Time (WBCT), Coagulometer, AMAG 977, Edoxaban
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision unrelated to safety
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ciraparantag Holdings GmbH
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 26 Aug 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 20 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Ciraparantag, Drug: Placebo, Device: Point-of-Care Coagulometer (investigational device)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. |
| Cohort 2 | Experimental | Drug: Ciraparantag, Drug: Placebo, Device: Point-of-Care Coagulometer (investigational device)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. |
| Cohort 3 | Experimental | Drug: Ciraparantag, Drug: Placebo, Device: Point-of-Care Coagulometer (investigational device)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written informed consent.
- 18 to 75 years of age.
- Be in generally good health
- BMI 18 to 32 kg/m2, inclusive, at Screening.
- 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.
Key exclusion criteria (28 listed)
- Have any of the following findings at Screening:
- 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 of any type, or vaginal delivery
- Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiraparantagAlso: PER977, AMAG 977Ciraparantag: 180 mg, intravenous | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboAlso: PBOPlacebo: 0.9% sodium chloride, intravenous | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Point-of-Care Coagulometer (investigational device)Also: CoagulometerPerosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time. | Device | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Subjects Achieving WBCT ≤120% of Baseline
Time frame: Within 1 hour and sustained through 6 hours
The primary efficacy endpoint is achieving a WBCT (measured by PoC coagulometer) ≤ 120% of baseline within 1 hour after administration of ciraparantag/PBO, which is subsequently sustained after 1 hour through at least 6 hours after ciraparantag/PBO dosing (Responder).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Advisor study director
Apollo Investment Management
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciraparantag and Point-of-Care Coagulometer (investigational device) in people with Healthy, run by AMAG Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects Achieving WBCT ≤120% of Baseline (time frame: Within 1 hour and sustained through 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.