Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2B Study to Evaluate the Efficacy of PB2452 in Reversal of Ticagrelor in Subjects Aged 50-80 Years Old

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122170
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.

Brief Summary:

This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of PB2452 in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of PB2452 in subjects aged 50-80 years old.

Approximately 200 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 PB2452 investigational study drug or placebo. Hence, a total of approximately 150 subjects will be receiving PB2452 and approximately 50 subjects will be receiving placebo.


Condition or disease Intervention/treatment Phase
Healthy Drug: Ticagrelor Oral Tablet - Pre-Treatment Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment Drug: PB2452 Infusion Drug: Placebo (0.9% Sodium chloride) infusion Phase 2

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 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 CYP3A inhibitor, a 36 g alternative regimen of 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2B, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy of PB2452 in Reversing Ticagrelor in Subjects Aged 50 to 80 Years Old
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Active Comparator: PB2452
PB2452 18 g Intravenous Infusion over a 16 hour duration.
Drug: Ticagrelor Oral Tablet - Pre-Treatment
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.

Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment
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.

Drug: PB2452 Infusion

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 Comparator: Placebo
Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.
Drug: Ticagrelor Oral Tablet - Pre-Treatment
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.

Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment
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.

Drug: Placebo (0.9% Sodium chloride) infusion
0.9% Sodium chloride Intravenous Infusion over a 16 hour duration




Primary Outcome Measures :
  1. Reversal effect of intravenous infusion of PB2452 compared to baseline - Minimum % inhibition of PRU (Verify Now) [ Time Frame: Four hours after the start of infusion (compared against pre-dose sample) ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo


Secondary Outcome Measures :
  1. Safety - Incidence and severity of AEs [ Time Frame: 83 days - Starting up to 45 days prior to dosing ]
  2. Safety - Incidence and severity of adverse events based on physical examination [ Time Frame: 83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 3, 7, and 35±3 ]
  3. Safety - Incidence of Clinical Laboratory Testing Abnormalities [ Time Frame: 83 days - Starting up to 45 days prior to dosing, pre-dose and Day 2, 7 and 35±3 ]
  4. Safety - Changes in Systolic Blood Pressure [ Time Frame: 83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3 ]
  5. Safety - Changes in Diastolic Blood Pressure [ Time Frame: 83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3 ]
  6. Safety - Changes in Oral Body Temperature [ Time Frame: 83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3 ]
  7. Safety - Changes in Respiratory Rate [ Time Frame: 83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3 ]
  8. Safety - Changes in Heart Rate [ Time Frame: 83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3 ]
  9. Safety - Incidence of clinically significant findings as measured by 12-Lead ECG [ Time Frame: 83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 7, and 35±3 ]
  10. Safety - Incidence of positive testing for Anti-Drug Antibodies [ Time Frame: 41 days - Starting 3 days prior to dosing and collected post-dose at Day 1, 7 and Day 35±3. May be extended in the event that result does not return to baseline in time allotted. ]
  11. Cmax (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion (exact sample times may be adjusted) ]
    Maximum concentration

  12. AUC (0-t) (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Area under the plasma concentration versus time curve from 0 to the time of the last quantifiable concentration (AUC0-t)

  13. Tmax (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Time to maximum concentration

  14. AUC0-24 (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24 hours after the start of infusion ]
    Area under the plasma concentration versus time curve 0-24 hours

  15. AUC0-48 (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Area under the plasma concentration versus time curve 0-48 hours

  16. AUC0-tau (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Area under the plasma concentration versus time curve from time zero to the time of the end of the dosing period

  17. AUC0-inf (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Area under the plasma concentration versus time curve at time 0 extrapolated to infinity

  18. t½ (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Terminal elimination half-life

  19. CL (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Clearance

  20. Vd (PB2452) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Volume of distribution

  21. Cmax (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Maximum concentration

  22. AUC0-last (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, and 12 hours after the start of infusion ]
    Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration

  23. Tmax (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Time to maximum concentration

  24. AUC(0-24) (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, and 24 hours after the start of infusion ]
    Area under the plasma concentration versus time curve 0-24 hours

  25. AUC(0-48) (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Area under the plasma concentration versus time curve 0-48 hours

  26. AUC0-tau (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Area under the plasma concentration versus time curve from time zero to the time of the end of the dosing period

  27. AUC0-inf (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Area under the plasma concentration versus time curve at time 0 extrapolated to infinity

  28. t½ (Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion ]
    Terminal elimination half-life

  29. Ae24 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and 0 to 6, 6 to 12, and 12 to 24 hours after the initiation of the PB2452 infusion. ]
    Total amount of drug excreted in urine at 24 hours

  30. Ae48 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and 0 to 6, 6 to 12, 12 to 24 and 24 to 48 hours after the initiation of the PB2452 infusion ]
    Total amount of drug excreted in urine at 48 hours

  31. Aet1-t2 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and 0 to 6, 6 to 12, 12 to 24 and 24 to 48 hours after the initiation of the PB2452 infusion ]
    Total amount of drug excreted in urine from time t1 to t2 hours

  32. Fe24 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and 0 to 6, 6 to 12, and 12 to 24 hours after the initiation of the PB2452 infusion and 5th ticagrelor dose. ]
    Fraction excreted in urine from 1 to 24 hours

  33. Fe48 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and 0 to 6, 6 to 12, 12 to 24 and 24 to 48 hours after the initiation of the PB2452 infusion and 5th ticagrelor dose ]
    Fraction excreted in urine from 1 to 48 hours

  34. CLr (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM)) [ Time Frame: Before dosing and 0 to 6, 6 to 12, and 12 to 24 hours after the initiation of the PB2452 infusion and 5th ticagrelor dose ]
    Renal clearance

  35. Reversal effects of intravenous infusion of PB2452 compared to baseline - Minimum % inhibition of PRI (VASP) [ Time Frame: Before dosing and at 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  36. Reversal effects of intravenous infusion of PB2452 compared to baseline - PRU (Verify Now) AUC [ Time Frame: Before dosing and at 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  37. Reversal effects of intravenous infusion of PB2452 - % of subjects to ≥ 180 PRU [ Time Frame: Before dosing and 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  38. Reversal effects of intravenous infusion of PB2452 - % of subjects to ≥ 60% of reversal in PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  39. Reversal effects of intravenous infusion of PB2452 - % of subjects to ≥ 80% of reversal in PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  40. Reversal effects of intravenous infusion of PB2452 - % of subjects to ≥ 100% of reversal in PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  41. Reversal effects of intravenous infusion of PB2452 - Time to ≥ 60% of reversal by PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  42. Reversal effects of intravenous infusion of PB2452 - Time to ≥ 80% of reversal by PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  43. Reversal effects of intravenous infusion of PB2452 - Time to ≥ 100% of reversal by PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  44. Reversal effects of intravenous infusion of PB2452 - Duration of 80% response rate by PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  45. Reversal effects of intravenous infusion of PB2452 - Duration of 100% response rate by PRU [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  46. Reversal effects of intravenous infusion of PB2452 - PRI AUC [ Time Frame: Before dosing and at 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  47. Reversal effects of intravenous infusion of PB2452 - % of subjects with ≥ 60% PRI response rate within 4 hours [ Time Frame: Before dosing and at 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  48. Reversal effects of intravenous infusion of PB2452 - % of subjects with ≥ 80% PRI response rate within 4 hours [ Time Frame: Before dosing and at 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  49. Reversal effects of intravenous infusion of PB2452 - % of subjects with ≥ 100% PRI response rate within 4 hours [ Time Frame: Before dosing and at 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  50. Reversal effects of intravenous infusion of PB2452 - Time to ≥ 60% of reversal by PRI [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  51. Reversal effects of intravenous infusion of PB2452 - Time to ≥ 80% of reversal by PRI [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  52. Reversal effects of intravenous infusion of PB2452 - Time to ≥ 100% of reversal by PRI [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  53. Reversal effects of intravenous infusion of PB2452 - Duration of 80% response rate by PRI [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  54. Reversal effects of intravenous infusion of PB2452 - Duration of 100% response rate by PRI [ Time Frame: Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  55. Reversal effects of intravenous infusion of PB2452 - % Reversal of PRU within 4 hours [ Time Frame: Before dosing and 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo

  56. Reversal effects of intravenous infusion of PB2452 - % Reversal of PRI within 4 hours [ Time Frame: Before dosing and 4 hours after the start of infusion ]
    Reversal of anti-platelet effects of ticagrelor with intravenous infusion of PB2452 or placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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].
  • 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 PB2452 or had been randomized to receive study drug in an earlier cohort for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122170


Locations
Layout table for location information
United States, California
WCCT Global, Inc. Recruiting
Cypress, California, United States, 90630
Contact: Katherine Kuehn    714-252-0700 ext 2535    Katherine.kuehn@wcct.com   
Principal Investigator: David Nguyen, MD         
Pacific Research Network Not yet recruiting
San Diego, California, United States, 92103
Contact: Dixie Creager    619-294-4302    dcreager@ergclinical.com   
Principal Investigator: Daniel Lawler, MD         
United States, Florida
Clinical Pharmacology of Miami, LLC Not yet recruiting
Miami, Florida, United States, 33014-3616
Contact: Cheryl Duggan    305-817-2900    cduggan@ergclinical.com   
Principal Investigator: Juan Carlos Rondon, MD         
PPD Development, LP Recruiting
Orlando, Florida, United States, 32806
Contact: Christopher Goolsby    689-216-3100    Christopher.goolsby@ppd.com   
Principal Investigator: James Taylor, MD         
United States, Kansas
Altasciences Clinical Kansas, Inc. Recruiting
Overland Park, Kansas, United States, 66212
Contact: Robert Wall    913-696-1601    regulatory@altasciences.com   
Principal Investigator: Martin Kankam, MD         
United States, Missouri
BioPharma Services USA Inc. (BPSUSA) Not yet recruiting
Saint Louis, Missouri, United States, 63141
Contact: Israa Diab    314-528-2222    diabi@biopharmaservices.com   
Principal Investigator: Artan Markollari, MD         
United States, Ohio
Aventiv Research Inc. Not yet recruiting
Columbus, Ohio, United States, 43213
Contact: Samir Arora, MD    614-501-6164    sarora@aventivresearch.com   
Principal Investigator: Samir Arora, MD         
Remington-Davis, Inc. Recruiting
Columbus, Ohio, United States, 43215
Contact: Diane Turnbull    614-487-2560    info@remdavis.com   
Principal Investigator: Edward Cordasco, Jr., DO, FCCP         
United States, South Carolina
VitaLink Research - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: Steve Clemons    864-770-0890    sclemons@vitalinkresearch.com   
Principal Investigator: Luis De La Cruz, MD         
VitaLink Research - Spartanburg Not yet recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Steve Clemons    864-565-0891    sclemons@vitalinkresearch.com   
Principal Investigator: Gregory Feldman, MD, CPI         
United States, Texas
PPD Development, LP Recruiting
Austin, Texas, United States, 78744
Contact: Antonia Davidson, MD    512-447-2985    antonia.davidson@ppdi.com   
Principal Investigator: Antonia Davidson, MD         
Sponsors and Collaborators
PhaseBio Pharmaceuticals Inc.
Layout table for additonal information
Responsible Party: PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04122170    
Other Study ID Numbers: PB2452-PT-CL-0003
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents