Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002925-39 | EudraCT Number |
Not provided
Not provided
Not provided
Trial cancelled before First Patient First Visit (no patient enrolled)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAA868 dose 1 | Experimental | MAA868 dose 1, single administration, subcutaneous |
|
| MAA868 dose 2 | Experimental | MAA868 dose 2, single administration, subcutaneous |
|
| Enoxaparin | Active Comparator | Enoxaparin 40mg, once daily (o.d.) for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAA868 | Drug | MAA868 dose 1 and dose 2, single administration, subcutaneous, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with confirmed composite endpoint | Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with composite bleeding | Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events | Day 1 to Day 50 |
| Number of patients with composite venous thromboembolic events (VTE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening).
Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI ≥ 40 kg/m2
Not provided
Not provided
Not provided
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000655065 | MAA868 |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided
Not provided
Not provided
Not provided
Open-label, blinded endpoint assessment
| Enoxaparin | Drug | Enoxaparin 40 mg, o.d X 10 days |
|
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death
| Day 1 to Day 110 |
| D002241 |
| Carbohydrates |