Trial Outcomes & Findings for Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure (NCT NCT03326843)

NCT ID: NCT03326843

Last Updated: 2020-04-15

Results Overview

Proportion of subjects that achieve a platelet count \>100 x 10\^9 platelets/L on procedure day

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline to 10-13 days
• Results posted on: 2020-04-15

Participant Flow

Participant milestones

Measure	Avatrombopag 60 mg Open-label: oral avatrombopag Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure

Baseline characteristics by cohort

Measure	Avatrombopag 60 mg n=4 Participants Open-label: oral avatrombopag Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants
Age, Continuous	66 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	4 participants n=93 Participants
Platelet Counts	68 10^9 platelets/L n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 10-13 days

Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day

Outcome measures

Measure	Avatrombopag 60 mg n=4 Participants Open-label: oral avatrombopag Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure.
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations	0.75 proportion of total participants

SECONDARY outcome

Timeframe: Up to 35 days

Population: Study was early terminated due to low enrollment

Incidence of treatment emergent adverse events

Outcome measures

Outcome data not reported

Adverse Events

Avatrombopag 60 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Avatrombopag 60 mg n=4 participants at risk Open-label: oral avatrombopag Avatrombopag 60 mg: Oral avatrombopag administered once daily for 5 days prior to procedure.
Infections and infestations Influenza	25.0% 1/4 • Number of events 1 • From the time of consent through study follow up visit, up to 35 days.
Infections and infestations Urinary Tract Infection	25.0% 1/4 • Number of events 1 • From the time of consent through study follow up visit, up to 35 days.
Renal and urinary disorders Urinary Retention	25.0% 1/4 • Number of events 1 • From the time of consent through study follow up visit, up to 35 days.
Metabolism and nutrition disorders Gout	25.0% 1/4 • Number of events 1 • From the time of consent through study follow up visit, up to 35 days.
Injury, poisoning and procedural complications Subcutaneous hematoma	25.0% 1/4 • Number of events 1 • From the time of consent through study follow up visit, up to 35 days.

Additional Information

Associate Director, Clinical Operations

Dova Pharmaceuticals

Phone: 919-338-7864

Email: clinical@dova.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER