Your session is about to expire
← Back to Search
Monoclonal Antibodies
Bentracimab for Bleeding or Emergency Surgery (REVERSE-IT Trial)
Phase 3
Recruiting
Research Sponsored by SFJ Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up any time point between infusion initiation and day 3 (pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and day 3)
Awards & highlights
REVERSE-IT Trial Summary
This trial will study the reversal of the antiplatelet drug ticagrelor in patients who have uncontrolled bleeding or who require surgery. Up to 200 patients will be enrolled at 200 centers in North America, Europe, and Asia-Pacific, including China.
Who is the study for?
This trial is for adults over 18 who've taken ticagrelor in the last 3 days and are facing uncontrolled major bleeding or need urgent surgery but can't wait due to high bleeding risk. It's not for those with certain drug sensitivities, recent use of other blood thinners, stable non-acute conditions, or if pregnancy is a concern.Check my eligibility
What is being tested?
The study tests Bentracimab (PB2452) infusion as a way to reverse ticagrelor's antiplatelet effects quickly in emergencies like severe bleeding or before an urgent surgery. Over 200 patients across multiple regions will be part of this single-arm trial where everyone receives the same treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions to the infusion such as discomfort at the injection site, allergic reactions, or other unforeseen complications related to reversing the antiplatelet effect.
REVERSE-IT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ any time point between infusion initiation and day 3 (pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and day 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~any time point between infusion initiation and day 3 (pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and day 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemostasis - Uncontrolled major of life-threatening bleeding - Achievement
Hemostasis - Urgent surgery or invasive procedure - Achievement
Reversal - Platelet Reactivity Units (PRU)
Secondary outcome measures
Duration of at least 100% reversal by PRU and PRI
Duration of at least 60% reversal by PRU and PRI
Duration of at least 80% reversal by PRU and PRI
+9 moreSide effects data
From 2021 Phase 2 trial • 207 Patients • NCT041221704%
Ecchymosis
4%
Headache
3%
Vessel puncture site bruise
3%
Contusion
2%
Nausea
2%
Diarrhoea
1%
Catheter site oedema
1%
Dizziness
1%
Pruritus
1%
Hiccups
1%
Throat irritation
1%
Asymptomatic COVID-19
1%
Chest discomfort
1%
Catheter site haemorrhage
1%
Dyspnoea
1%
Oedema
1%
Catheter site bruise
1%
Infusion site extravasation
1%
Chest pain
1%
Infusion site pruritus
1%
Pain
1%
Vessel puncture site erythema
1%
Constipation
1%
Injection site haemorrhage
1%
Infusion related reaction
1%
Skin abrasion
1%
Injection site reaction
1%
Crepitations
1%
Dermatitis contact
1%
Rash
1%
Flushing
1%
Thrombophlebitis
1%
Blood creatine phosphokinase increased
1%
COVID-19
1%
Anaemia
1%
Pain in extremity
1%
Thermal burn
1%
Infusion site erythema
1%
Injection site phlebitis
1%
Urticaria
1%
Back pain
1%
Epistaxis
1%
Hot flush
1%
Occult blood
1%
Arthralgia
1%
Joint swelling
1%
Fatigue
1%
Thrombophlebitis superficial
1%
Haematoma
1%
Phlebitis
1%
Occult blood positive
1%
Hypertriglyceridaemia
1%
Administration site bruise
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bentracimab (PB2452)
Placebo
REVERSE-IT Trial Design
1Treatment groups
Experimental Treatment
Group I: Bentracimab (PB2452) Infusion - Open Label Active DrugExperimental Treatment1 Intervention
Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration. For patients with uncontrolled major or life-threatening bleeding or in need of urgent surgery or invasive procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bentracimab (PB2452) Infusion
2019
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
SFJ Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
966 Total Patients Enrolled
PhaseBio Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
1,335 Total Patients Enrolled
Deepak Bhatt, MD, MPHStudy ChairBrigham and Women's Hospital, Division of Cardiovascular Medicine
1 Previous Clinical Trials
7,500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at high risk for serious complications from bleeding due to my age or heart/lung condition.I need urgent surgery that has a high risk of significant bleeding.I need ticagrelor reversal but it's not urgent. I might have low hemoglobin from ongoing minor GI bleeding or stable brain bleeding.I have had significant bleeding and needed blood transfusions.I have had bleeding in a critical area like the brain, eye, or joints.I haven't taken certain blood thinners or platelet inhibitors recently.My condition is considered beyond the help of curative treatment.I am allergic to PB2452 or its ingredients.I am over 18 and have given my consent to participate.I need urgent surgery but cannot wait due to a high risk of bleeding.I have severe bleeding that needs immediate treatment to reverse the effects of ticagrelor.I have taken ticagrelor in the last 3 days.I have had severe bleeding that affected my blood pressure and heart function.I have not used specific blood clotting treatments in the last 5 days.I need urgent surgery that could be risky if my blood doesn't clot well.
Research Study Groups:
This trial has the following groups:- Group 1: Bentracimab (PB2452) Infusion - Open Label Active Drug
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other ongoing Bentracimab (PB2452) Infusion research projects?
"PB2452 Infusion is being trialled in 1 study that is still recruiting patients. Of the Bentracimab (PB2452) Infusion trials, this one is in Phase 3. Although the majority of clinical research locations for this treatment are in Hamilton, Ontario, there are a total of 94 sites running these investigations."
Answered by AI
Has the FDA cleared Bentracimab (PB2452) Infusion for use?
"There is some efficacy data and multiple rounds of safety data, so the Power team rates Bentracimab (PB2452) Infusion as a 3 on a scale from 1 to 3."
Answered by AI
How does this research compare to similar projects?
"Since 2020, PhaseBio Pharmaceuticals Inc. has been sponsoring research into Bentracimab (PB2452) Infusion. In 2020, the first clinical trial was completed with 200 participants. This study allowed for the drug to progress to Phase 3 of approval. As of now, there is a single active trial being conducted by PhaseBio Pharmaceuticals Inc.."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger