HealthyPhase 2NCT03172910
Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT
A Phase 2 study testing Ciraparantag and Rivaroxaban in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban measuring clotting times using Whole Blood Clotting Time (WBCT). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ciraparantag and Rivaroxaban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 12 Nov 2019
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
General Inclusion Criteria:
- Adults age 50 to 75 years
- Laboratory tests (chemistry, hematology and coagulation assessments) and urinalysis performed during screening up to 36 days prior to administration of study treatment deemed not clinically significant by the principal investigator.
- No clinically significant findings on 12-lead electrocardiogram (ECG) performed during screening
- Body mass index (BMI) 18 to ≤ 32 kg/m2, inclusive
- Male subjects agree to use appropriate contraception in addition to their partner using an acceptable form of contraception, when engaging in sexual activity during the course of the study. Moreover, male subjects should not donate sperm or attempt to impregnate a partner during the course of the study and for a period of 12 weeks following discharge from the study.
- Female subjects must have a negative urine pregnancy test at screening AND: be surgically sterile OR postmenopausal for the last three months, OR in a monogamous relation with a male partner who has undergone a documented vasectomy a minimum of 6 months prior to study commencement. All females must agree to continue to use their method of birth control for the duration of the study and for a minimum of one complete menstrual cycle or 28 days following discharge from the study
- Subjects who have participated in a prior study of ciraparantag must have been discharged from the study a minimum of 1 month prior to the planned treatment.
- Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign the informed consent form indicating voluntary consent to participate in the study prior to initiation of screening or study-related activities
General Exclusion Criteria:
- History of major bleeding or clotting disorder
- Females with a history of dysfunctional uterine bleeding
- Smokers or use of tobacco and/or nicotine containing products within 3 months prior to dosing as determined by the subject's verbal history
- Pregnant or breast-feeding
- Males with a history of hormone therapy within 3 months prior to screening
- Taking any type of chronic medication (including vitamin, nutritional and herbal supplements) for more than 14 consecutive days within the 4 weeks prior to study entry (use of hormonal contraceptives is acceptable)
- Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus antibody (HCV-Ab), or Hepatitis B surface antigen (HBsAg)
- Donation of blood or blood products within 56 days prior to screening
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services Inc.
Secaucus, New Jersey, 07094
About this study
Official title: Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT
This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban measuring clotting times using Whole Blood Clotting Time (WBCT).
Read the detailed description
This is a randomized, single-blind, placebo-controlled assessment of the efficacy and safety of ciraparantag administered to healthy volunteers measuring clotting times using WBCT as determined by the manual testing method. All subjects will undergo screening up to 36 days prior to enrollment.
All enrolled subjects are to receive a single dose of 20 mg rivaroxaban in the morning on Days 1-3. On Day 3 (3.75 hours post rivaroxaban), subjects who have a minimum increase in clotting time of 25% (as measured by WBCT) are randomized and will receive a single IV dose 4 hours after the rivaroxaban dose, followed by serial testing of manual WBCT.
Subjects are enrolled sequentially in up to 4 ciraparantag dose cohorts. There will be a safety review after completion of treatment in one cohort and prior to initiation of treatment in the subsequent cohort.
- Conditions
- Healthy
- Being tested
- Ciraparantag, Placebo, Rivaroxaban
- Keywords
- PER977, Ciraparantag, Whole Blood Clotting Time (WBCT), Rivaroxaban
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 (administered over 10 minutes)
PlaceboDrug
Also called PBO
Saline for injection
RivaroxabanDrug
Rivaroxaban 20 mg given once per day (QD) in the morning
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | ciraparantag (60 mg) Receives: Drug: Ciraparantag; Drug: Rivaroxaban |
| Cohort 2 | Experimental | ciraparantag (120 mg) Receives: Drug: Ciraparantag; Drug: Rivaroxaban |
| Cohort 3 | Experimental | ciraparantag (180 mg) Receives: Drug: Ciraparantag; Drug: Rivaroxaban |
| Cohort 4 | Experimental | ciraparantag (30 mg) Receives: Drug: Ciraparantag; Drug: Rivaroxaban |
| Placebo | Placebo comparator | placebo (saline for injection) Receives: Drug: Placebo; Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Achieving Complete Reversal of Anticoagulation (WBCT is ≤ 110% of Baseline)
Complete reversal is achieved if WBCT (manual method) is ≤ 110% of baseline at any post-baseline time point up to and including 1 hour following ciraparantag/placebo administration)
Measured: Within 1 Hour
Subjects Achieving Complete and Sustained Reversal of Anticoagulation (WBCT is ≤115%of Baseline)
Complete and sustained reversal of anticoagulation is achieved for a subject if WBCT (manual method) is ≤ 115% of baseline at all time points between 1 and 8 hours (inclusive) following ciraparantag/placebo administration.
Measured: Between 1 and 8 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start8 May 2017
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172910
- Sponsor's protocol ID
- PER977-02-012
- Status last verified
- Aug 2025
- First submitted
- 19 May 2017
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT
- ClinicalTrials.gov ID
- NCT03172910
- Acronym / sponsor ID
- PER977-02-012
- Conditions
- Healthy
- Keywords
- PER977, Ciraparantag, Whole Blood Clotting Time (WBCT), Rivaroxaban
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Posted 2 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban measuring clotting times using Whole Blood Clotting Time (WBCT).
Detailed description
This is a randomized, single-blind, placebo-controlled assessment of the efficacy and safety of ciraparantag administered to healthy volunteers measuring clotting times using WBCT as determined by the manual testing method. All subjects will undergo screening up to 36 days prior to enrollment.
All enrolled subjects are to receive a single dose of 20 mg rivaroxaban in the morning on Days 1-3. On Day 3 (3.75 hours post rivaroxaban), subjects who have a minimum increase in clotting time of 25% (as measured by WBCT) are randomized and will receive a single IV dose 4 hours after the rivaroxaban dose, followed by serial testing of manual WBCT.
Subjects are enrolled sequentially in up to 4 ciraparantag dose cohorts. There will be a safety review after completion of treatment in one cohort and prior to initiation of treatment in the subsequent cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Ciraparantag, Drug: Rivaroxabanciraparantag (60 mg) |
| Cohort 2 | Experimental | Drug: Ciraparantag, Drug: Rivaroxabanciraparantag (120 mg) |
| Cohort 3 | Experimental | Drug: Ciraparantag, Drug: Rivaroxabanciraparantag (180 mg) |
| Cohort 4 | Experimental | Drug: Ciraparantag, Drug: Rivaroxabanciraparantag (30 mg) |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Rivaroxabanplacebo (saline for injection) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 (administered over 10 minutes) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboAlso: PBOSaline for injection | Drug | Placebo |
| RivaroxabanRivaroxaban 20 mg given once per day (QD) in the morning | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Placebo |
Primary outcome
Subjects Achieving Complete Reversal of Anticoagulation (WBCT is ≤ 110% of Baseline)
Time frame: Within 1 Hour
Complete reversal is achieved if WBCT (manual method) is ≤ 110% of baseline at any post-baseline time point up to and including 1 hour following ciraparantag/placebo administration)
Subjects Achieving Complete and Sustained Reversal of Anticoagulation (WBCT is ≤115%of Baseline)
Time frame: Between 1 and 8 Hours
Complete and sustained reversal of anticoagulation is achieved for a subject if WBCT (manual method) is ≤ 115% of baseline at all time points between 1 and 8 hours (inclusive) following ciraparantag/placebo administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Rivaroxaban in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. at 1 site 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?
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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 Sep 2025). 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 Complete Reversal of Anticoagulation (WBCT is ≤ 110% of Baseline) (time frame: Within 1 Hour). The study lists 2 primary outcomes in all. 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 2 Sep 2025.