NCT01734044

rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP

A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.

Detailed description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 200 primary ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count was evaluated before and after treatment, in order to report the conversion ratio of primary ITP to chronic ITP.

Conditions

• Purpura
• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	recombinant human thrombopoietin (rhTPO); dexamethasone	Patients in recombination treatment group take rhTPO( subcutaneously , 300U/kg for 14 consecutive days, followed by flexible treating dosage so as to keep the platelet count above 50×10\^9/L until the 28th day), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days)
DRUG	Dexamethasone	Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-07-01
• Completion: 2014-11-01
• First posted: 2012-11-27
• Last updated: 2016-04-20

Locations

1 site across 1 country: China