A Study to Compare Avatrombopag with Standard Treatment for Adults with Chronic Liver Disease and Low Platelet Count Who Need a Planned Medical Procedure

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Avatrombopag Tablet 20 mg: Pateints will receive either receive Avatrombopag Tablets 40 mg or 60 mg once daily for 5 consecutive days Control Intervention1: Standard of care: Pateints will receive Standard of Care once daily for 5 consecutive days as per PI Discretion CONDITION: Health Condition 1: D696‐ Thrombocytopenia, unspecified PRIMARY OUTCOME: Proportion of Participants who do not require platelet transfusion or any rescue procedure for bleedingTimepoint: After randomization upto 7 days following an elective procedure SECONDARY OUTCOME: The proportion of Participants who achieve platelet count above 50000 per microliter prior to platelet transfusion or undergoing elective procedure ; Change in platelet count on procedure day prior to platelet transfusion on undergoing elective procedure ; The proportion of Participants requiring platelet transfusion ; Incidence and severity of bleeding symptoms associated with CLD measured using the World Health Organization WHO Bleeding Scale ; Timepoint: On procedure day ; From baseline to Procedure day ; ; INCLUSION CRITERIA: Male or female subjects between 18 and 65 years of age with a diagnosis of chronic liver disease scheduled to undergo a procedure Written informed consent for participation in the study by the subject and the subjects legally acceptable representative and willingness to adhere to protocol requirements Participants who are clinically stable with no significant change in prescribed medications or hospitalization within 14 days before randomization Participants with a platelet count of less than fifty multiplied by ten to the power of nine per litre Adults with chronic liver disease and a Model for End Stage Liver Disease score of 24 or less who are scheduled to undergo an elective procedure and require a platelet transfusion Women of childbearing potential must have a negative serum or urine pregnancy test at the screening or baseline visit Subjects who in the opinion of the principal investigator are able to
Epistemonikos ID: 19362f4d1de6f51e77d7daa10bdae7e7f4e76f50
First added on: Oct 08, 2026