NCT01805648

Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP

A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking Union Medical College · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .

Detailed description

The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10\^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10\^9/L～100 ×10\^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Platelet transfusion will be administered to subjects with active bleeding symptoms. Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.

Conditions

• Thrombocytopenia
• Immune Thrombocytopenia
• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	rhTPO	Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10\^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10\^9/L～100×10\^9/L.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2013-03-06
• Last updated: 2013-03-06

Locations

1 site across 1 country: China