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RECRUITING
NCT07911800
PHASE3

Phase 3 Study of rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.

Sponsor: MIBIO PTE. LTD.

View on ClinicalTrials.gov

Summary

This is a global, multicenter, randomized, double-blind, placebo-controlled study using recombinant human thrombopoietin stimulating factor ( rhTPO) to treat adults with Chronic liver disease-related thrombocytopenia (CLDT). The study will evaluate rhTPO efficacy in elevating platelet level and its safety in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce pre-procedural platelet transfusion needs and the requirements for rescue treatment for bleeding.

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia in Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10-20

Completion Date

2028-10-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

rhTPO

For subcutaneous injection once daily, for up to 5 or 7 days

DRUG

Placebo

For subcutaneous injection once daily, for up to 5 or 7 days

Locations (2)

Caucasus Medical Center LLC

Tbilisi, Georgia

Geo Hospitals LLC

Tbilisi, Georgia