Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
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| ClinicalTrials.gov Identifier: NCT03326843 |
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Recruitment Status :
Terminated
(Study was terminated due to enrollment challenges.)
First Posted : October 31, 2017
Results First Posted : April 15, 2020
Last Update Posted : April 15, 2020
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Sponsor:
Sobi, Inc.
Information provided by (Responsible Party):
Sobi, Inc.
- Study Details
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thrombocytopenia | Drug: Avatrombopag 60 mg | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure |
| Actual Study Start Date : | March 26, 2018 |
| Actual Primary Completion Date : | February 25, 2019 |
| Actual Study Completion Date : | February 25, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Avatrombopag 60 mg
Open-label: oral avatrombopag
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Drug: Avatrombopag 60 mg
Oral avatrombopag administered once daily for 5 days prior to procedure. |
Primary Outcome Measures :
- Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations [ Time Frame: Baseline to 10-13 days ]Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day
Secondary Outcome Measures :
- Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events [ Time Frame: Up to 35 days ]Incidence of treatment emergent adverse events
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women greater than or equal to 18 years of age;
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A mean baseline platelet count between:
- 50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants
- 50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease;
- 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:
- Participant with a history of arterial or venous thrombosis within 6 months of baseline;
- Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of baseline;
- Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit;
- Use of erythropoietin-stimulating agents;
- Participant has a known medical history of genetic prothrombotic syndromes; or
- Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326843
Locations
| United States, Arkansas | |
| Dova Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Dova Site | |
| Coronado, California, United States, 92118 | |
| United States, Colorado | |
| Dova Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Dova Site | |
| Jacksonville, Florida, United States, 32209 | |
| Dova Site | |
| Jacksonville, Florida, United States, 32224 | |
| Dova Site | |
| Miami, Florida, United States, 33135 | |
| Dova Site | |
| Miami, Florida, United States, 33136 | |
| Dova Site | |
| Pensacola, Florida, United States, 32503 | |
| Dova Site | |
| Sarasota, Florida, United States, 34232 | |
| Dova Site | |
| Tamarac, Florida, United States, 33321 | |
| Dova Site | |
| Tampa, Florida, United States, 33615 | |
| United States, Louisiana | |
| Dova Site | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Dova Site | |
| Baltimore, Maryland, United States, 21202 | |
| United States, Massachusetts | |
| Dova Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Dova Site | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| Dova Site | |
| Saint Louis, Missouri, United States, 63110 | |
| Dova Site | |
| Springfield, Missouri, United States, 65807 | |
| United States, Nevada | |
| Dova Site | |
| Reno, Nevada, United States, 89503 | |
| United States, New Jersey | |
| Dova Site | |
| Englewood, New Jersey, United States, 07631 | |
| United States, New York | |
| Dova Site | |
| Buffalo, New York, United States, 14203 | |
| United States, North Carolina | |
| Dova Site | |
| Durham, North Carolina, United States, 27710 | |
| Dova Site | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Dova Site | |
| Toledo, Ohio, United States, 43606 | |
| United States, Pennsylvania | |
| Dova Site | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| United States, Texas | |
| Dova Site | |
| Austin, Texas, United States, 78731 | |
| United States, Virginia | |
| Dova Site | |
| Newport News, Virginia, United States, 23602 | |
| United States, Wisconsin | |
| Dova Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Sobi, Inc.
Study Documents (Full-Text)
Documents provided by Sobi, Inc.:
Documents provided by Sobi, Inc.:
Study Protocol [PDF] September 17, 2018
Statistical Analysis Plan [PDF] January 22, 2019
| Responsible Party: | Sobi, Inc. |
| ClinicalTrials.gov Identifier: | NCT03326843 |
| Other Study ID Numbers: |
AVA-PST-320 |
| First Posted: | October 31, 2017 Key Record Dates |
| Results First Posted: | April 15, 2020 |
| Last Update Posted: | April 15, 2020 |
| Last Verified: | May 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Sobi, Inc.:
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low platelet count ITP |
Additional relevant MeSH terms:
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Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |