Phase IbII Study of Single Subcutaneous Dose of PN20 for Treating Thrombocytopenia in Adults with Chronic Liver Disease Undergoing Elective Procedures

What this Trial Is About

Researchers are studying the safety and effectiveness of a single dose of PN20 in treating thrombocytopenia in adult patients with chronic liver disease who are undergoing elective procedures. This phase IbII trial aims to find out how well PN20 works and if it is safe for these patients, who have a low platelet count and specific liver disease conditions. The study is open-label in phase Ib and randomized, double-blind, placebo-controlled in phase II. The study has two stages phase Ib involves giving single doses of PN20 at increasing levels to small groups of patients to evaluate safety and dosing. Phase II randomly assigns patients to receive either one or two selected PN20 dose levels or a placebo via a single subcutaneous injection before their elective procedure. The doses used in phase II depend on the results from phase Ib. Participants will receive one injection and attend clinic visits for assessment. Researchers will monitor the proportion of patients who respond within 8 days around the surgery, as well as adverse events, drug levels in the body, and immune responses up to 28 days after dosing. The study lasts about one month per participant, focusing on safety, tolerability, and treatment effects.

A Study to Evaluate the Safety and Efficacy of PN20 in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure