Clinical trial NCT03326843: Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Thrombocytopenia
Keywords: low platelet count
ITP
Lead sponsor: Sobi, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women greater than or equal to 18 years of age;
* 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

Primary outcomes:
measure: Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations
timeFrame: Baseline to 10-13 days
Secondary outcomes:
measure: Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
timeFrame: Up to 35 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Dova Site
state: Arkansas
city: Coronado
country: United States
facility: Dova Site
state: California
city: Aurora
country: United States
facility: Dova Site
state: Colorado
city: Jacksonville
country: United States
facility: Dova Site
state: Florida
city: Jacksonville
country: United States
facility: Dova Site
state: Florida
city: Miami
country: United States
facility: Dova Site
state: Florida
city: Miami
country: United States
facility: Dova Site
state: Florida
city: Pensacola
country: United States
facility: Dova Site
state: Florida
city: Sarasota
country: United States
facility: Dova Site
state: Florida
city: Tamarac
country: United States
facility: Dova Site
state: Florida
city: Tampa
country: United States
facility: Dova Site
state: Florida
city: New Orleans
country: United States
facility: Dova Site
state: Louisiana
city: Baltimore
country: United States
facility: Dova Site
state: Maryland
city: Boston
country: United States
facility: Dova Site
state: Massachusetts
city: Detroit
country: United States
facility: Dova Site
state: Michigan
city: Saint Louis
country: United States
facility: Dova Site
state: Missouri
city: Springfield
country: United States
facility: Dova Site
state: Missouri
city: Reno
country: United States
facility: Dova Site
state: Nevada
city: Englewood
country: United States
facility: Dova Site
state: New Jersey
city: Buffalo
country: United States
facility: Dova Site
state: New York
city: Durham
country: United States
facility: Dova Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Dova Site
state: North Carolina
city: Toledo
country: United States
facility: Dova Site
state: Ohio
city: Bethlehem
country: United States
facility: Dova Site
state: Pennsylvania
city: Austin
country: United States
facility: Dova Site
state: Texas
city: Newport News
country: United States
facility: Dova Site
state: Virginia
city: Milwaukee
country: United States
facility: Dova Site
state: Wisconsin
Study officials:
References: