A Phase 2 interventional study of JNJ-64179375 0.3 mg/kg and JNJ-64179375 0.6 mg/kg in VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery, sponsored by Janssen Research & Development, LLC. Completed at 103 sites in 16 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-11-25.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2, Interventional, and Prevention
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).
This study has 2 parts, dose escalation and dose-response evaluation, and will be conducted in participants undergoing primary unilateral elective Total Knee Replacement (TKR) surgery. Participants will participate in either Part 1 or Part 2 of study only. The study will be conducted in 3 phases: an up to 30-day screening phase before surgery, a 14-day double-blind dosing phase, and a 16-week follow-up phase. Safety evaluations will include monitoring of all nonserious and serious adverse events, clinical laboratory tests, vital signs measurements, and physical examinations. Pharmacokinetics (dense and sparse), pharmacodynamic (PD), health resource utilization, and immunogenicity samples will also be assessed. The total study duration of participant's participation in Part 1 or part 2 after randomization will be approximately 18 weeks.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenously (IV) or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 0.3 mg/kg · Drug: Placebo JNJ-64179375 · Drug: Apixaban placebo · Drug: Apixaban 2.5 mg
Participants will receive JNJ-64179375 0.6 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 0.6 mg/kg · Drug: Placebo JNJ-64179375 · Drug: Apixaban placebo · Drug: Apixaban 2.5 mg
Participants will receive JNJ-64179375 1.2 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 1.2 mg/kg · Drug: Placebo JNJ-64179375 · Drug: Apixaban placebo · Drug: Apixaban 2.5 mg
Participants will receive JNJ-64179375 Dose to be determined (TBD) based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 (Dose to be Determined) · Drug: Placebo JNJ-64179375 · Drug: Apixaban placebo · Drug: Apixaban 2.5 mg
Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 (Dose to be Determined) · Drug: Placebo JNJ-64179375 · Drug: Apixaban placebo · Drug: Apixaban 2.5 mg
Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 (Dose to be Determined) · Drug: Placebo JNJ-64179375 · Drug: Apixaban placebo · Drug: Apixaban 2.5 mg
Participants will receive JNJ-64179375 Dose A mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 A mg/kg · Drug: Apixaban placebo
Participants will receive JNJ-64179375 Dose B mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 B mg/kg · Drug: Apixaban placebo
Participants will receive JNJ-64179375 Dose C mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 C mg/kg · Drug: Apixaban placebo
Participants will receive JNJ-64179375 Dose D mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
Drug: JNJ-64179375 D mg/kg · Drug: Apixaban placebo
Participants will receive JNJ-64179375 placebo (saline) IV as a single dose on Day 1 and apixaban 2.5 mg orally twice a day for 10 to 14 days.
Drug: Placebo JNJ-64179375 · Drug: Apixaban 2.5 mg
Drug page: Ichorcumab
JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.
Drug page: Ichorcumab
JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.
Drug page: Ichorcumab
JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.
JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.
Drug page: Ichorcumab
JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.
Drug page: Ichorcumab
JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.
Drug page: Ichorcumab
JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.
Drug page: Ichorcumab
JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.
Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.
Matching apixaban placebo administered orally twice a day for 10 to 14 days.
Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.
Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)
Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)
Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Major Bleeding Event (CEC-adjudicated)
Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)
Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)
Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
Time frame: Up to Day 10 and 14 (visit observation period)
Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Major VTE (CEC-adjudicated)
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Death (CEC-adjudicated)
Number of participants with death (adjudicated by CEC) were reported.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Proximal and Distal DVT (CEC-adjudicated)
Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
Time frame: Up to Day 10 to 14 (visit observation period)
Number of Participants With Distal DVT (CEC-adjudicated)
Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Time frame: Up to Day 10 to 14 (visit observation period)
| Milestone | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Started | 39 | 41 | 43 | 122 | 63 |
| Treated | 38 | 40 | 42 | 122 | 63 |
| Completed | 39 | 40 | 43 | 122 | 63 |
| Not completed | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 |
Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) | 2 | 0 | 5 | 1 | 4 |
Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) | 10 | 9 | 9 | 31 | 6 |
Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated) | 1 | 0 | 2 | 1 | 0 |
Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Major Bleeding Event (CEC-adjudicated) | 0 | 0 | 0 | 0 | 0 |
Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated) | 1 | 0 | 2 | 1 | 0 |
Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated) | 1 | 0 | 2 | 1 | 0 |
Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Minimal Bleeding Events (CEC-adjudicated) | 2 | 0 | 4 | 0 | 4 |
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Major VTE (CEC-adjudicated) | 2 | 2 | 1 | 7 | 0 |
Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Asymptomatic | 1 | 2 | 0 | 3 | 0 |
| Symptomatic | 0 | 0 | 0 | 2 | 0 |
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) | 0 | 0 | 0 | 0 | 0 |
Number of participants with death (adjudicated by CEC) were reported.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Number of Participants With Death (CEC-adjudicated) | 0 | 0 | 0 | 0 | 0 |
Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Asymptomatic | 1 | 0 | 1 | 4 | 0 |
| Symptomatic | 0 | 0 | 0 | 0 | 0 |
Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
| Participants | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Asymptomatic | 8 | 7 | 8 | 24 | 6 |
| Symptomatic | 0 | 0 | 0 | 1 | 1 |
Collected over Up to 18 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| JNJ-64179375 0.3 mg/kg and Apixaban Placebo | 0/38 (0%) | 2/38 (5.3%) | 19/38 (50%) |
| JNJ-64179375 0.6 mg/kg and Apixaban Placebo | 0/40 (0%) | 2/40 (5%) | 17/40 (42.5%) |
| JNJ-64179375 1.2 mg/kg and Apixaban Placebo | 0/42 (0%) | 4/42 (9.5%) | 26/42 (61.9%) |
| JNJ-64179375 1.8 mg/kg and Apixaban Placebo | 0/122 (0%) | 13/122 (10.7%) | 37/122 (30.3%) |
| Apixaban 2.5 mg and JNJ-64179375 Placebo IV | 0/63 (0%) | 5/63 (7.9%) | 20/63 (31.7%) |
| Event | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| Deep Vein ThrombosisVascular disorders | 0/38 | 0/40 | 1/42 | 6/122 | 0/63 |
| OverdoseInjury, poisoning and procedural complications | 1/38 | 0/40 | 0/42 | 0/122 | 0/63 |
| Bloody DischargeVascular disorders | 1/38 | 0/40 | 0/42 | 0/122 | 0/63 |
| Peripheral SwellingGeneral disorders | 0/38 | 1/40 | 0/42 | 0/122 | 0/63 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/38 | 1/40 | 0/42 | 0/122 | 0/63 |
| Impaired HealingGeneral disorders | 0/38 | 0/40 | 1/42 | 0/122 | 0/63 |
| InfectionInfections and infestations | 0/38 | 0/40 | 1/42 | 0/122 | 0/63 |
| Tendon RuptureInjury, poisoning and procedural complications | 0/38 | 0/40 | 1/42 | 0/122 | 0/63 |
| Wound HaemorrhageInjury, poisoning and procedural complications | 0/38 | 0/40 | 1/42 | 0/122 | 0/63 |
| HaemarthrosisMusculoskeletal and connective tissue disorders | 0/38 | 0/40 | 1/42 | 0/122 | 0/63 |
| Event | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV |
|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 6/38 | 0/40 | 0/42 | 8/122 | 1/63 |
| NauseaGastrointestinal disorders | 1/38 | 3/40 | 5/42 | 3/122 | 0/63 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/38 | 0/40 | 5/42 | 3/122 | 0/63 |
| Urinary Tract InfectionInfections and infestations | 0/38 | 0/40 | 3/42 | 1/122 | 1/63 |
| ContusionInjury, poisoning and procedural complications | 0/38 | 0/40 | 3/42 | 0/122 | 1/63 |
| Wound HaemorrhageInjury, poisoning and procedural complications | 0/38 | 0/40 | 3/42 | 0/122 | 0/63 |
| ConstipationGastrointestinal disorders | 2/38 | 0/40 | 0/42 | 1/122 | 2/63 |
| Wound InfectionInfections and infestations | 2/38 | 0/40 | 0/42 | 0/122 | 0/63 |
| Deep Vein ThrombosisVascular disorders | 2/38 | 1/40 | 0/42 | 2/122 | 3/63 |
| ThrombophlebitisVascular disorders | 2/38 | 0/40 | 1/42 | 0/122 | 0/63 |
Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).
| Age, Continuous(years) | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Total |
|---|---|---|---|---|---|---|
| Mean | 66.2 ± 7.53 | 65.8 ± 8.14 | 66.9 ± 6.41 | 67.2 ± 8.84 | 65.1 ± 7.01 | 66.4 ± 7.92 |
| Sex: Female, Male(Participants) | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Total |
|---|---|---|---|---|---|---|
| Female | 21 | 25 | 35 | 99 | 42 | 222 |
| Male | 17 | 15 | 7 | 23 | 21 | 83 |
| Race/Ethnicity, Customized(Participants) | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Total |
|---|---|---|---|---|---|---|
| Asian | 0 | 0 | 2 | 9 | 5 | 16 |
| Black | 1 | 0 | 0 | 1 | 1 | 3 |
| White | 36 | 39 | 39 | 110 | 54 | 278 |
| Unspecified | 1 | 1 | 1 | 2 | 3 | 8 |
| Region of Enrollment(Participants) | JNJ-64179375 0.3 mg/kg and Apixaban Placebo | JNJ-64179375 0.6 mg/kg and Apixaban Placebo | JNJ-64179375 1.2 mg/kg and Apixaban Placebo | JNJ-64179375 1.8 mg/kg and Apixaban Placebo | Apixaban 2.5 mg and JNJ-64179375 Placebo IV | Total |
|---|---|---|---|---|---|---|
| Argentina | 2 | 4 | 3 | 8 | 10 | 27 |
| Belgium | 5 | 3 | 3 | 2 | 3 | 16 |
| Bulgaria | 0 | 0 | 0 | 2 | 0 | 2 |
| Canada | 0 | 0 | 0 | 3 | 0 | 3 |
| Italy | 0 | 1 | 0 | 5 | 2 | 8 |
| Japan | 0 | 0 | 2 | 5 | 5 | 12 |
| Latvia | 0 | 0 | 0 | 8 | 4 | 12 |
| Lithuania | 0 | 0 | 3 | 8 | 1 | 12 |
| Malaysia | 0 | 0 | 0 | 4 | 0 | 4 |
| Poland | 17 | 9 | 4 | 18 | 12 | 60 |
| Russian Federation | 0 | 0 | 2 | 9 | 3 | 14 |
| Spain | 3 | 3 | 3 | 7 | 2 | 18 |
| Turkey | 1 | 7 | 5 | 8 | 2 | 23 |
| Ukraine | 0 | 4 | 7 | 20 | 7 | 38 |
| United States | 10 | 9 | 10 | 15 | 12 | 56 |
Showing the first 100 of 103 sites across 16 countries. Choose a country and city above to see the rest.
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Studies of the drugs tested here: Ichorcumab · Apixaban
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