Phase 3
Completed N=12
LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures
Hemophilia
Source: ClinicalTrials.gov NCT02548143 ↗
Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Surgical or Other Invasive Procedures Defined as "Good" or "Excellent" Response to LR769 Treatment as Assessed by the Investigator, Based on the Totality of the Assessments Performed on the Patient — 4; 5; 2; 0 Surgeries
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgical or other invasive procedures. Administration of LR769 will be performed just prior to surgery/procedure and will be repeated during and after the surgery/procedure to achieve and maintain adequate hemostasis as determined by the investigator's judgment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Surgical or Other Invasive Procedures Defined as "Good" or "Excellent" Response to LR769 Treatment as Assessed by the Investigator, Based on the Totality of the Assessments Performed on the Patient |
4; 5; 2; 0 | — |
| SECONDARY Percentages of Success as Defined as the Combination of "Good" and "Excellent" Responses by the Investigator or Designee |
5; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
Each patient must meet the following criteria to be enrolled in this study:
- be male with a diagnosis of congenital hemophilia A or B of any severity
- have one of the following:
- a positive inhibitor test Bethesda Unit (BU) ≥5 (as confirmed at screening by the institutional lab), OR
- a BU 200/µL)
- known intolerance to LR769 or any of its excipients
- currently receiving immune tolerance induction (ITI) therapy
- have a known allergy or hypersensitivity to rabbits
- have a platelet count 3 times the upper limit of normal (ULN)) and/or renal impairment (creatinine >2 times the ULN)
- have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis (DVT) or pulmonary embolism (PE)) within 2 years prior to the planned first dose of LR769, uncontrolled arrhythmia, or current New York Heart Association (NYHA) functional classification score of stages II - IV
- have an active malignancy (those with non-melanoma skin cancer are allowed)
- have any life-threatening disease or other disease or condition which, according to the investigator's judgment, could imply a potential hazard to the patient, or interfere with the trial participation or trial outcome (eg, a history of non-responsiveness to bypassing products)
- be using aspirin, NSAIDS, herbs, natural medications, or other drugs with platelet inhibitory properties within one week prior to surgery and for the duration of treatment with LR769
- have active gastric or duodenal ulcer disease
Data sourced from ClinicalTrials.gov (NCT02548143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.