Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is researching experimental drugs called REGN9933 and REGN7508 (called "study drugs") and comparing their effects to approved treatments of rivaroxaban and aspirin (called "standard treatments"). Aspirin will be given alone or in combination with the study drugs or the other standard treatments to look at their effects on blood loss in the intestines.
The aim of the study is to see if aspirin alone or the study drugs REGN9933 and REGN7508, when taken with aspirin, cause less minor intestinal bleeding than standard treatments rivaroxaban with aspirin.
The study is looking at several other research questions, including:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Aspirin | Active Comparator | Randomized 1:1:1:1 |
|
| Arm 2: Aspirin + REGN9933 | Experimental | Randomized 1:1:1:1 |
|
| Arm 3: Aspirin + REGN7508 | Experimental | Randomized 1:1:1:1 |
|
| Arm 4: Aspirin + Rivaroxaban | Active Comparator | Randomized 1:1:1:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal hemoglobin content (FHC) | Baseline and up to day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAE) | Up to day 100 | |
| Severity of TEAE | Up to day 100 | |
| Incidence of major bleeding |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Development | Leeds | LS11 9EH | United Kingdom |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| REGN9933 | Drug | Administered intravenous (IV) |
|
| REGN7508 | Drug | Administered IV |
|
| Rivaroxaban | Drug | Oral administration |
|
| Up to day 100 |
| Incidence of clinically relevant non-major (CRNM) bleeding | Up to day 100 |
| Concentrations of REGN9933 | Up to day 29 |
| Concentrations of REGN7508 | Up to day 29 |
| Change in activated partial thromboplastin time (aPTT) | Baseline and up day 29 |
| Change in prothrombin time (PT) | Baseline and up day 29 |
| Incidence of Anti-drug antibody (ADA) to REGN9933 | Up to day 29 |
| Titer of ADA to REGN9933 | Up to day 29 |
| Incidence of ADA to REGN7508 | Up to day 29 |
| Titer of ADA to REGN7508 | Up to day 29 |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided