NCT03326843

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

Terminated Phase 3 Results posted Last updated 15 April 2020

What this trial tests

Phase 3 trial testing Avatrombopag 60 mg in Thrombocytopenia in 4 participants. Terminated before completion.

Timeline

26 March 2018

Primary endpoint
25 February 2019

25 February 2019

Quick facts

Lead sponsor	Sobi, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	26 March 2018
Primary completion	25 February 2019
Estimated completion	25 February 2019
Sites	27 locations across United States

Drugs / interventions tested

• Avatrombopag 60 mg — full drug profile →

Conditions studied

• Thrombocytopenia — all drugs for Thrombocytopenia →

Sponsor

Sobi, Inc. — full company profile →

Who can join

18 and older, any sex, with Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations Primary · Baseline to 10-13 days

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

Group	Value	95% CI
Avatrombopag 60 mg	0.75

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of consent through study follow up visit, up to 35 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Avatrombopag 60 mg

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (5 terms — click to expand)

Reaction	System	Avatrombopag 60 mg
Influenza	Infections and infestations	—
Urinary Tract Infection	Infections and infestations	—
Urinary Retention	Renal and urinary disorders	—
Gout	Metabolism and nutrition disorders	—
Subcutaneous hematoma	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT03326843 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia.
   Jurczak W, Chojnowski K, Mayer J, Krawczyk K, et al · · 2018 · cited 156× · PMID 30191972 · DOI 10.1111/bjh.15573
2. Avatrombopag, an oral thrombopoietin receptor agonist: results of two double-blind, dose-rising, placebo-controlled Phase 1 studies.
   Kuter DJ, Allen LF. · · 2018 · cited 31× · PMID 30203841 · DOI 10.1111/bjh.15574
3. Current Advance in Thrombopoietin Receptor Agonists in the Management of Thrombocytopenia Associated With Chronic Liver Disease: Focus on Avatrombopag.
   Abdela J. · · 2019 · cited 9× · PMID 31673229 · DOI 10.1177/1179545x19875105