Randomized Study to Evaluate the Safety and Efficacy of Oral JNJ-70033093 Versus Enoxaparin in Subjects Undergoing Elective Total Knee Replacement
- Conditions
- Thromboembolism in subjects who have undergone an elective primary unilateral total knee replacementMedDRA version: 21.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-004237-32-BG
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
Male or female.
50 years of age, or older.
Medically stable and appropriate for anticoagulant prophylaxis as determined by the investigator on the basis of physical examination, medical history, and vital signs performed as part of screening for elective TKR surgery.
Medically stable and appropriate for anticoagulant prophylaxis on the basis of clinical laboratory tests performed as part of local standard-of-care as part of screening for elective TKR surgery. If the results of laboratory tests are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject’s source documents and initialed by the investigator.
Has plans to undergo an elective primary unilateral TKR surgery.
Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
A woman of childbearing potential (WOCBP) must have a negative urine or highly sensitive serum (Beta human chorionic gonadotropin) up to 2 days before the administration of the study drug.
A woman must be (as defined in the protocol Section 10.5, Appendix 5, Contraceptive and Barrier Guidance and Collection of Pregnancy Information).
a. Not of childbearing potential
b. Of childbearing potential and
o Practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to
remain on a highly effective method for the duration of study drug with JNJ-70033093 plus 5 half-lives of study drug plus 30 days (duration of
ovulatory cycle) for a total of 34 days after the completion of treatment.
Examples of highly effective methods of contraception are located in
Section 10.5, Appendix 5, Contraceptive and Barrier Guidance and
Collection of Pregnancy Information.
o Pregnancy testing (serum or urine) prior to the first dose of study drug.
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 34 days
after the last dose.
A male subject must wear a condom when engaging in any activity with a WOCBP during the study and for the duration of treatment with JNJ-
70033093 plus 5 half-lives of the study drug plus 90 day (duration of sperm turnover) for a total of 94 days after the completion of treatment.
Male subjects should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break
or leak. This criterion does not apply to male subjects randomly assigned to enoxaparin.
A male subject must agree not to donate sperm for the purpose of reproduction during the study and for the duration of treatment with
JNJ-70033093 plus 5 half-lives of the study drug plus 90 days (duration of sperm turnover) for a total of 94 days after the completion of
treatment. This criterion does not apply to male subjects randomly assigned to enoxaparin.
Willing and able to adhere to the lifestyle restrictions (Section 5.3, Lifestyle Considerations) specified in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 511
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for th
History of any condition for which the use of LMWH is not recommended in the opinion of the investigator (eg, previous allergic reaction, creatinine clearance <30 mL/minute).
History of severe hepatic impairment.
Planned bilateral revision or unicompartmental procedure.
Planned postoperative epidural analgesia with an epidural catheter.
•If an epidural catheter was used, it must be removed at least 5 hours prior to postoperative study drug administration.
NOTE: if a subject had an epidural or spinal anesthesia procedure with bleeding or significant trauma at the time of surgery, they should not be
randomized.
Unable to undergo venography (eg, due to contrast agent allergy, poor venous access, or impaired renal function that would increase the risk of
contrast-induced nephropathy).
Known previous PE or DVT in either lower extremity.
Known allergies, hypersensitivity, or intolerance to JNJ-70033093 or its excipients (refer to IB).
Contraindications to the use of or known allergies, hypersensitivities, or intolerance to enoxaparin per local prescribing information (eg, heparin
and pork products).
Any condition requiring chronic antithrombotic therapy (eg, atrial fibrillation, mechanical heart valve, recent coronary intervention), except for aspirin less than or equal to 100 mg per day.
Use of strong CYP3A4/P-gp inhibitors or strong CYP3A4/P-gp inducers in the 7 days prior to randomization or the need for ongoing treatment with concomitant oral or IV therapy with strong CYP3A4/P-gp inhibitors or strong CYP3A4/P-gp inducers during the treatment period.
Taken any disallowed therapies as noted in the protocol Section 6.5, Concomitant Therapy before the planned first dose of study drug.
Planned use of intermittent pneumatic compression after the first postoperative dose of the study drug.
Received an investigational study drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the planned first dose of study drug or is currently enrolled in an investigational study.
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Has surgery planned (except the TKR study) during the time the subject is expected to participate in the study for which anticoagulant therapy would be interrupted.
Previously randomized subject in this study or participated in previous studies with JNJ 70033093.
Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
At the time of informed consent, the subject does not agree to following up with scheduled study visits or allowing a telephone contact to the subject’s alternative means of contact (eg subject’s children, spouse, significant other, caretaker, legal representative, healthcare professional), as necessary, until the end of the study, should he or she discontinue prematurely.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method