HealthyPhase 2NCT04122170
Phase 2B Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversal of Ticagrelor in Subjects Aged 50-80 Years Old
A Phase 2 study testing Ticagrelor Oral Tablet - Pre-Treatment, Aspirin (ASA) Oral Tablet - Pre-Treatment and Bentracimab (PB2452) Infusion in people with Healthy, run by SFJ Pharmaceuticals, Inc. at 15 sites in 2 countries.
Trial summary
This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ticagrelor Oral Tablet - Pre-Treatment, Aspirin (ASA) Oral Tablet - Pre-Treatment and Bentracimab (PB2452) Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 24 Sep 2019to 1 Sep 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject provides written or verbal informed consent (in-person or remotely) and agrees to comply with all protocol requirements throughout study participation.
- The subject is male or female between ≥50 and ≤80 years of age.
- The subject has a body mass index between 18 and 35 kg/m2 and a weight of ≥ 50 kg but ≤ 120 kg, inclusive, at screening.
- The subject is considered by the Investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination findings at screening and Check-in. Subjects with chronic, stable, and well-controlled medical conditions, are eligible provided they meet all other inclusion/exclusion criteria.
- The subject has specific inclusionary laboratory values at screening and check-in: white blood cell (WBC) count, platelet count, haemoglobin level, thyroid-stimulating hormone (TSH) level, and prothrombin time (PT) and partial thromboplastin time (PTT) levels within the normal range.
- Subjects taking medications for well-controlled medical conditions must have been on a stable dose for at least 30 days prior to screening visit.
- Subjects entering the study must be willing to start and/or document an 81 mg daily dose of aspirin on Day -7 and must document daily dosing until the final dose is administered on the morning of Day 1. Subjects already taking daily aspirin must suspend aspirin dosing after Day 1 until discharge from the clinical facility.
- Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant for 3 months after the last dose of study drug. Female subjects of childbearing potential must use two effective methods of birth control from screening and before study drug administration through to the end of the study.
Who cannot join
- In the opinion of the Investigator there are concern(s) regarding the inability of the subject to comply with study procedures and/or follow up, or, if the subject is not suitable for entry into the study.
- History of any acute or chronic medical disorder expected to decrease the life expectancy of the subject to an extent where the subject's study participation is affected.
- Any clinically significant acute illness, medical/surgical procedure, or trauma within 4 weeks of the administration of study drug or any planned surgical procedure that will occur during the study.
- Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during screening or check-in.
- Any specific contraindication to ticagrelor as described in the ticagrelor prescribing information.
- Receiving chronic treatment with nonsteroidal anti-inflammatory drugs [including aspirin (>100 mg daily), anticoagulants, or other antiplatelet agents that cannot be discontinued 14 days prior to screening including clopidogrel, prasugrel, ticlopidine, dipyridamole, or cilostazol].
Show all 11Show fewer
- First positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
- Has received another investigational drug within 30 days of the administration of study drug in this study or within 5 half-lives of the experimental medication, whichever is longer.
- History of severe or ongoing allergy/hypersensitivity to any biologic therapeutic agent.
- Involvement with any PhaseBio or study site employee or their close relatives (e.g., spouse, parents, siblings, or children whether biological or legally adopted).
- Previously received Bentracimab (PB2452) or had been randomized to receive study drug in an earlier cohort for this study
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Rebecca Wood-Horrall
Austin, Texas, 78744
Aventiv Research Inc.
Columbus, Ohio, 43213
Remington-Davis, Inc.
Columbus, Ohio, 43215
WCCT Global, Inc.
Cypress, California, 90630
VitaLink Research - Greenville
Greenville, South Carolina, 29615
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014-3616
Monroe Biomedical Research
Monroe, North Carolina, 28112
PPD Development, LP
Orlando, Florida, 32806
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758
Pacific Research Network
San Diego, California, 92103
VitaLink Research - Spartanburg
Spartanburg, South Carolina, 29303
BioPharma Services USA Inc. (BPSUSA)
St Louis, Missouri, 63141
Canada2 sites
Altasciences Company Inc.
Mount Royal, Quebec, H3P 3P1
BioPharma Services Inc.
Toronto, Ontario, M9L 3A2
About this study
Official title: A Phase 2B, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversing Ticagrelor in Subjects Aged 50 to 80 Years Old
This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab (PB2452) in subjects aged 50-80 years old.
A total of 205 subjects between 50-80 years old will be enrolled in the US or other countries at the discretion of the Sponsor across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the bentracimab (PB2452) investigational study drug or placebo. Hence, a total of 154 subjects will be receiving bentracimab (PB2452) and approximately 51 subjects will be receiving placebo.
Read the detailed description
The study will consist of a Screening period, a Check-in day, an on-site Randomization/Treatment day, a 2-day on-site Follow-up period (Days 2 through 3), a Follow-up visit (Day 7), and a Final Follow-up visit (Day 35±3). If needed and at the discretion of the Investigator, a subject may remain in the study facility beyond the scheduled Day 3 discharge to accommodate Day 7 and Day 35±3 follow-up visits. Seven days prior to enrollment, subjects will be administered ASA 81 mg orally once daily (QD) until the final dose on Day 1. Beginning in the morning on Day -2, a single dose of oral ticagrelor 180 mg will be given, followed by oral ticagrelor 90 mg every 12 hours for 4 additional doses through to Day 1 (2 hours before study drug is initiated; this will be 5 total doses of ticagrelor).
On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized with 3:1 allocation ratio (active:placebo), to receive an IV dose of bentracimab (PB2452) or placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the clinical site on Day 3 and will return for a Follow-up visit on Day 7, if already discharged, and on Day 35 (±3 days). A subject may remain in the study facility beyond the scheduled Day 3 discharge to accommodate Day 7 and Day 35±3 follow-up visits.
If a subject is taking a moderate or strong cytochrome P450 3A isozyme (CYP3A) inhibitor, a 36 g alternative regimen of bentracimab (PB2452) will be administered consisting of 12 g infused over 10 minutes followed by a 12 g loading dose infused over 6 hours, then a maintenance dose of 12 g infused over the next 18 hours immediately following completion of the loading period for a total infusion time of approximately 24 hours.
- Conditions
- Healthy
- Being tested
- Ticagrelor Oral Tablet - Pre-Treatment, Aspirin (ASA) Oral Tablet - Pre-Treatment, Bentracimab (PB2452) Infusion, Placebo (0.9% Sodium chloride) infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor Oral Tablet - Pre-TreatmentDrug
Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-TreatmentDrug
Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) InfusionDrug
Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration
In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.
Placebo (0.9% Sodium chloride) infusionDrug
0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
| Study group | Role | What they receive |
|---|---|---|
| Bentracimab (PB2452) | Active comparator | PB2452 18 g Intravenous Infusion over a 16 hour duration. Receives: Drug: Ticagrelor Oral Tablet - Pre-Treatment; Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment; Drug: Bentracimab (PB2452) Infusion |
| Placebo | Placebo comparator | Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration. Receives: Drug: Ticagrelor Oral Tablet - Pre-Treatment; Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment; Drug: Placebo (0.9% Sodium chloride) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Minimum Percent Inhibition Platelet Reactivity Unit (PRU) Assessed by VerifyNow™ PRUTest™ From Baseline to Within 4 Hours After Study Drug Start.
Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo
Measured: Baseline (pre-dose) to 4 hours after the start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start24 Sep 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- SFJ Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122170
- Sponsor's protocol ID
- PB2452-PT-CL-0003
- Status last verified
- Feb 2024
- First submitted
- 4 Oct 2019
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversing Ticagrelor in Subjects Aged 50 to 80 Years Old
- ClinicalTrials.gov ID
- NCT04122170
- Acronym / sponsor ID
- PB2452-PT-CL-0003
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- SFJ Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab (PB2452) in subjects aged 50-80 years old.
A total of 205 subjects between 50-80 years old will be enrolled in the US or other countries at the discretion of the Sponsor across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the bentracimab (PB2452) investigational study drug or placebo. Hence, a total of 154 subjects will be receiving bentracimab (PB2452) and approximately 51 subjects will be receiving placebo.
Detailed description
The study will consist of a Screening period, a Check-in day, an on-site Randomization/Treatment day, a 2-day on-site Follow-up period (Days 2 through 3), a Follow-up visit (Day 7), and a Final Follow-up visit (Day 35±3). If needed and at the discretion of the Investigator, a subject may remain in the study facility beyond the scheduled Day 3 discharge to accommodate Day 7 and Day 35±3 follow-up visits. Seven days prior to enrollment, subjects will be administered ASA 81 mg orally once daily (QD) until the final dose on Day 1. Beginning in the morning on Day -2, a single dose of oral ticagrelor 180 mg will be given, followed by oral ticagrelor 90 mg every 12 hours for 4 additional doses through to Day 1 (2 hours before study drug is initiated; this will be 5 total doses of ticagrelor).
On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized with 3:1 allocation ratio (active:placebo), to receive an IV dose of bentracimab (PB2452) or placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the clinical site on Day 3 and will return for a Follow-up visit on Day 7, if already discharged, and on Day 35 (±3 days). A subject may remain in the study facility beyond the scheduled Day 3 discharge to accommodate Day 7 and Day 35±3 follow-up visits.
If a subject is taking a moderate or strong cytochrome P450 3A isozyme (CYP3A) inhibitor, a 36 g alternative regimen of bentracimab (PB2452) will be administered consisting of 12 g infused over 10 minutes followed by a 12 g loading dose infused over 6 hours, then a maintenance dose of 12 g infused over the next 18 hours immediately following completion of the loading period for a total infusion time of approximately 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bentracimab (PB2452) | Active comparator | Drug: Ticagrelor Oral Tablet - Pre-Treatment, Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment, Drug: Bentracimab (PB2452) InfusionPB2452 18 g Intravenous Infusion over a 16 hour duration. |
| Placebo | Placebo comparator | Drug: Ticagrelor Oral Tablet - Pre-Treatment, Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment, Drug: Placebo (0.9% Sodium chloride) infusionPlacebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject provides written or verbal informed consent (in-person or remotely) and agrees to comply with all protocol requirements throughout study participation.
- The subject is male or female between ≥50 and ≤80 years of age.
- The subject has a body mass index between 18 and 35 kg/m2 and a weight of ≥ 50 kg but ≤ 120 kg, inclusive, at screening.
- The subject is considered by the Investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination findings at screening and Check-in. Subjects with chronic, stable, and well-controlled medical conditions, are eligible provided they meet all other inclusion/exclusion criteria.
- The subject has specific inclusionary laboratory values at screening and check-in: white blood cell (WBC) count, platelet count, haemoglobin level, thyroid-stimulating hormone (TSH) level, and prothrombin time (PT) and partial thromboplastin time (PTT) levels within the normal range.
Key exclusion criteria (11 listed)
- In the opinion of the Investigator there are concern(s) regarding the inability of the subject to comply with study procedures and/or follow up, or, if the subject is not suitable for entry into the study.
- History of any acute or chronic medical disorder expected to decrease the life expectancy of the subject to an extent where the subject's study participation is affected.
- Any clinically significant acute illness, medical/surgical procedure, or trauma within 4 weeks of the administration of study drug or any planned surgical procedure that will occur during the study.
- Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during screening or check-in.
- Any specific contraindication to ticagrelor as described in the ticagrelor prescribing information.
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 |
|---|---|---|
| Ticagrelor Oral Tablet - Pre-TreatmentTicagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses. | Drug | Bentracimab (PB2452), Placebo |
| Aspirin (ASA) Oral Tablet - Pre-TreatmentAspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only. | Drug | Bentracimab (PB2452), Placebo |
| Bentracimab (PB2452) InfusionBentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion. | Drug | Bentracimab (PB2452) |
| Placebo (0.9% Sodium chloride) infusion0.9% Sodium chloride Intravenous Infusion over a 16 hour duration | Drug | Placebo |
Primary outcome
Comparison of Minimum Percent Inhibition Platelet Reactivity Unit (PRU) Assessed by VerifyNow™ PRUTest™ From Baseline to Within 4 Hours After Study Drug Start.
Time frame: Baseline (pre-dose) to 4 hours after the start of infusion
Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ticagrelor Oral Tablet - Pre-Treatment, Aspirin (ASA) Oral Tablet - Pre-Treatment and Bentracimab (PB2452) Infusion in people with Healthy, run by SFJ Pharmaceuticals, Inc. at 15 sites in 2 countries.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. 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 8 Apr 2024). 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?
Comparison of Minimum Percent Inhibition Platelet Reactivity Unit (PRU) Assessed by VerifyNow™ PRUTest™ From Baseline to Within 4 Hours After Study Drug Start. (time frame: Baseline (pre-dose) to 4 hours after the start of infusion). 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 8 Apr 2024.