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Phase 3 Study of rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Sponsor: MIBIO PTE. LTD.
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
rhTPO
For subcutaneous injection once daily, for up to 5 or 7 days
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