--- title: Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure nct_id: NCT03326843 overall_status: TERMINATED phase: PHASE3 sponsor: Sobi, Inc. study_type: INTERVENTIONAL primary_condition: Thrombocytopenia countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03326843.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03326843" ct_last_update_post_date: 2020-04-15 last_seen_at: "2026-05-12T06:46:56.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT03326843](https://clinicaltrials.gov/study/NCT03326843) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** Study was terminated due to enrollment challenges. - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 4 - **Lead Sponsor:** Sobi, Inc. - **Conditions:** Thrombocytopenia - **Start Date:** 2018-03-26 - **Completion Date:** 2019-02-25 - **CT.gov Last Update:** 2020-04-15 ## 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Avatrombopag 60 mg** (EXPERIMENTAL) — Open-label: oral avatrombopag ## Interventions - **Avatrombopag 60 mg** (DRUG) — Oral avatrombopag administered once daily for 5 days prior to procedure. ## Primary Outcomes - **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 Outcomes - **Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events** _(time frame: Up to 35 days)_ ## Locations (27) - Dova Site, Little Rock, Arkansas, United States - Dova Site, Coronado, California, United States - Dova Site, Aurora, Colorado, United States - Dova Site, Jacksonville, Florida, United States - Dova Site, Jacksonville, Florida, United States - Dova Site, Miami, Florida, United States - Dova Site, Miami, Florida, United States - Dova Site, Pensacola, Florida, United States - Dova Site, Sarasota, Florida, United States - Dova Site, Tamarac, Florida, United States - Dova Site, Tampa, Florida, United States - Dova Site, New Orleans, Louisiana, United States - Dova Site, Baltimore, Maryland, United States - Dova Site, Boston, Massachusetts, United States - Dova Site, Detroit, Michigan, United States - Dova Site, Springfield, Missouri, United States - Dova Site, St Louis, Missouri, United States - Dova Site, Reno, Nevada, United States - Dova Site, Englewood, New Jersey, United States - Dova Site, Buffalo, New York, United States - Dova Site, Durham, North Carolina, United States - Dova Site, Winston-Salem, North Carolina, United States - Dova Site, Toledo, Ohio, United States - Dova Site, Bethlehem, Pennsylvania, United States - Dova Site, Austin, Texas, United States - Dova Site, Newport News, Virginia, United States - Dova Site, Milwaukee, Wisconsin, United States ## Recent Field Changes (last 30 days) - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.dova site|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.dova site|coronado|california|united states` — added _(2026-05-12)_ - `locations.dova site|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.dova site|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.dova site|miami|florida|united states` — added _(2026-05-12)_ - `locations.dova site|pensacola|florida|united states` — added _(2026-05-12)_ - `locations.dova site|sarasota|florida|united states` — added _(2026-05-12)_ - `locations.dova site|tamarac|florida|united states` — added _(2026-05-12)_ - `locations.dova site|tampa|florida|united states` — added _(2026-05-12)_ - `locations.dova site|new orleans|louisiana|united states` — added _(2026-05-12)_ - `locations.dova site|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.dova site|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.dova site|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.dova site|springfield|missouri|united states` — added _(2026-05-12)_ - `locations.dova site|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.dova site|reno|nevada|united states` — added _(2026-05-12)_ - `locations.dova site|englewood|new jersey|united states` — added _(2026-05-12)_ - `locations.dova site|buffalo|new york|united states` — added _(2026-05-12)_ - `locations.dova site|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.dova site|winston-salem|north carolina|united states` — added _(2026-05-12)_ - `locations.dova site|toledo|ohio|united states` — added _(2026-05-12)_ - `locations.dova site|bethlehem|pennsylvania|united states` — added _(2026-05-12)_ - `locations.dova site|austin|texas|united states` — added _(2026-05-12)_ - `locations.dova site|newport news|virginia|united states` — added _(2026-05-12)_ - `locations.dova site|milwaukee|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03326843.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03326843* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*