Not provided
Not provided
Not provided
Not provided
Not provided
Study was terminated due to enrollment challenges.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.
Subjects will receive oral avatrombopag once daily for 5 days beginning on Day 1, followed by a wait period prior to the procedure, which will occur on Day 10 to 13. The Follow-up Period will include 2 visits; 7 days post-procedure and 30 days after last dose.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avatrombopag 60 mg | Experimental | Open-label: oral avatrombopag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag 60 mg | Drug | Oral avatrombopag administered once daily for 5 days prior to procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations | Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day | Baseline to 10-13 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events | Incidence of treatment emergent adverse events | Up to 35 days |
Not provided
Inclusion Criteria:
Men and women greater than or equal to 18 years of age;
A mean baseline platelet count between:
Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dova Site | Little Rock | Arkansas | 72205 | United States | ||
| Dova Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Avatrombopag 60 mg | Open-label: oral avatrombopag Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2018 | Feb 5, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Coronado |
| California |
| 92118 |
| United States |
| Dova Site | Aurora | Colorado | 80045 | United States |
| Dova Site | Jacksonville | Florida | 32209 | United States |
| Dova Site | Jacksonville | Florida | 32224 | United States |
| Dova Site | Miami | Florida | 33135 | United States |
| Dova Site | Miami | Florida | 33136 | United States |
| Dova Site | Pensacola | Florida | 32503 | United States |
| Dova Site | Sarasota | Florida | 34232 | United States |
| Dova Site | Tamarac | Florida | 33321 | United States |
| Dova Site | Tampa | Florida | 33615 | United States |
| Dova Site | New Orleans | Louisiana | 70112 | United States |
| Dova Site | Baltimore | Maryland | 21202 | United States |
| Dova Site | Boston | Massachusetts | 02115 | United States |
| Dova Site | Detroit | Michigan | 48202 | United States |
| Dova Site | Springfield | Missouri | 65807 | United States |
| Dova Site | St Louis | Missouri | 63110 | United States |
| Dova Site | Reno | Nevada | 89503 | United States |
| Dova Site | Englewood | New Jersey | 07631 | United States |
| Dova Site | Buffalo | New York | 14203 | United States |
| Dova Site | Durham | North Carolina | 27710 | United States |
| Dova Site | Winston-Salem | North Carolina | 27157 | United States |
| Dova Site | Toledo | Ohio | 43606 | United States |
| Dova Site | Bethlehem | Pennsylvania | 18015 | United States |
| Dova Site | Austin | Texas | 78731 | United States |
| Dova Site | Newport News | Virginia | 23602 | United States |
| Dova Site | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Avatrombopag 60 mg | Open-label: oral avatrombopag Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Platelet Counts | Mean | Full Range | 10^9 platelets/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations | Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day | Posted | Number | proportion of total participants | Baseline to 10-13 days |
|
|
| |||||||||||||||||||||||||||
| Secondary | Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events | Incidence of treatment emergent adverse events | Study was early terminated due to low enrollment | Posted | Up to 35 days |
|
|
From the time of consent through study follow up visit, up to 35 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avatrombopag 60 mg | Open-label: oral avatrombopag Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure. | 0 | 4 | 0 | 4 | 4 | 4 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Subcutaneous hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
Following a multicenter publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Institution shall remove from the proposed publication any information that is considered confidential other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Operations | Dova Pharmaceuticals | 919-338-7864 | clinical@dova.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2019 | Feb 5, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C533238 | avatrombopag |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|