NCT05193201

A Phase Ib Clinical Study for rhTPO in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease

A Multicenter Phase Ib Clinical Study for Recombinant Human Thrombopoietin Injection in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the multiple-dose regimen of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease.

Detailed description

This is a multi-center, open label, phase Ib clinical study. The effectiveness of the multiple-dose regimen of recombinant human thrombopoietin injection in the treatment of thrombocytopenia in patients with chronic liver disease is mainly verified by evaluating the proportion of responders with platelet count in the first 8 days after treatment. Cohort 1 (n=18) : 50\*10\^9/L ≤ Baseline of PLT \< 75\*10\^9/L. Cohort 2 (n=36) : 30\*10\^9/L ≤ Baseline of PLT \< 50\*10\^9/L.

Conditions

• Liver Disease Chronic
• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	recombinant human thrombopoietin injection	recombinant human thrombopoietin: 15000 U subcutaneous injection once a day for 7 days

Timeline

• Start date: 2022-01-16
• Primary completion: 2022-10-16
• Completion: 2022-12-31
• First posted: 2022-01-14
• Last updated: 2022-01-14

Locations

1 site across 1 country: China