A Phase 3, Multicenter, Open-Label, Single-Arm Study of PB2452 in Ticagrelor-Treated Patients with Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure (REVERSE-IT Trial)
- Conditions
- blood and lymphatic system disorders, Uncontrolled Major or Life Threatening Bleeding or Requiring Urgent, Surgery or Invasive ProcedureTicagrelor-Treated Patients with Uncontrolled Bleeding
- Registration Number
- NL-OMON54454
- Lead Sponsor
- SFJ Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
1. Male or female > 18 years of age with documented or verbal informed
consent. Emergency consent may be obtained where permitted by local regulations
and institutional approval. 2. History or documentation of ticagrelor intake
within the prior 3 days 3. Patients described below who require urgent reversal
of the antiplatelet effects of ticagrelor: Patients with uncontrolled major or
life-threatening bleeding, requiring urgent reversal of the antiplatelet
effects of ticagrelor. It is expected that enrolled patients would have
characteristics similar to those described below: • Potentially
life-threatening bleeding with signs or symptoms of hemodynamic compromise,
e.g., systolic blood pressure < 90 mm Hg and signs or symptoms of low
cardiac output not otherwise explained • Bleeding in a critical organ or closed
space, such as intracranial, intraspinal, intraocular, retroperitoneal, intra*
articular, pericardial, or intramuscular bleed with compartment syndrome •
Visible, uncontrolled bleeding associated with a corrected hemoglobin level
< 8.0 g/dL, a fall in hemoglobin level of >= 2.0 g/dL (1.24 mmol/L) from a
known baseline, or requirement for transfusion of 2 or more units of packed red
blood cells (PRBC) Patients requiring urgent surgery or invasive procedure when
it is not medically advisable either to proceed urgently with impaired
hemostasis or to delay the urgent procedure for 3 or more days due to the high
risk of bleeding. These patients may typically be in any of the following
clinical situations: • Requires urgent surgery or invasive procedure known to
be associated with a risk of significant bleeding (such as cardiac surgery,
neurosurgery, or major orthopedic surgery) • Requires urgent surgery or
invasive procedure that may have an adverse procedural outcome if hemostasis is
impaired (such as neurological, spinal, ophthalmological, urological, or
orthopedic surgery) • At risk of experiencing life-threatening events, such as,
shock, myocardial infarction, or stroke, if significant intraoperative or
postoperative bleeding occurs (such as in elderly patients or patients with
underlying cardiac or pulmonary disease who have limited cardiopulmonary
reserve)
1. Known sensitivity or contraindication to PB2452 or any of its excipients 2.
Patients in whom ticagrelor reversal is not considered urgent, e.g., patients
with stable or non-acute conditions who have low hemoglobin due to chronic,
low-grade gastrointestinal bleeding or who have stable, remote, or asymptomatic
intracranial hemorrhage. 3. Patients expected to be clinically unsalvageable,
such as patients with end-stage cancer or patients with overwhelming sepsis. 4.
Any condition which, in the opinion of the investigator, would make it unsafe
or unsuitable for the patients to participate in this study. This includes
assessment of likelihood to cooperate with study follow-up visits and
procedures • Known pregnancy may be exclusionary in some regions or countries
as directed by national health authorities and/or local IRBs/Ethics Committees
5. Known use of clopidogrel, prasugrel, or ticlopidine within 5 days of study
drug administration; known use of antiplatelet GPIIb/IIIa inhibitors, or
cangrelor within 5 half-lives of study drug administration; or known use of
warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 5 half-lives of
expected study drug administration 6. Known recent use (< 5 day) of vitamin
K, prothrombin complex concentrate, recombinant factor VIIa, idarucizumab, or
andexanet-alfa (coagulation factor Xa (recombinant), inactivated-zhzo).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method