Open-label Study Measuring Safety and Treatment Satisfaction in Adult Subjects With Chronic Immune Thrombocytopenia (ITP) After Switching to Avatrombopag From Eltrombopag or Romiplostim
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|ClinicalTrials.gov Identifier: NCT04638829|
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : June 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Avatrombopag Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multi-center, Open-label Study Measuring Safety and Treatment Satisfaction in Adult Subjects With Chronic Immune Thrombocytopenia (ITP) After Switching to Avatrombopag From Eltrombopag or Romiplostim|
|Actual Study Start Date :||March 15, 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Avatrombopag 20 mg oral tablet formulation for 90 days
Drug: Avatrombopag Oral Tablet
Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information
- Safety and Tolerability (adverse events) [ Time Frame: Screening through Day 90 or End of Study ]
Safety and Tolerability of Avatrombopag given for 90 days after stopping eltrombopag or romiplostim
The incidence and severity of adverse events (AEs), serious adverse events(SAE) and adverse events of special interest will be summarized for all enrolled subjects using counts and percentages. Treatment-emergent AEs and SAEs will be summarized overall, by system organ class, and by preferred term. AESIs will be summarized by event type (thromboembolic events and bleeding events). In addition, treatment-emergent AEs will be summarized by severity and by relationship to study drug.
Bleeding events reported during the study will be summarized by WHO grade.
- Subject reported outcomes [ Time Frame: Screening through Day 90 or End of Study ]Evaluate the change in subject reported outcomes(TSQM questionnaire) from Baseline after switching to avatrombopag from eltrombopag or romiplostim.
- Platelet counts [ Time Frame: Screening through Day 90 or End of Study ]Evaluate the platelet counts after switching to avatrombopag from eltrombopag or romiplostim.
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): NCT04638829
|Contact: Dova Clinicalfirstname.lastname@example.org|
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68506|
|United States, Ohio|
|Columbus, Ohio, United States, 43223|
|United States, South Carolina|
|Lancaster, South Carolina, United States, 29720|
|Rock Hill, South Carolina, United States, 29732|