NCT02757196

Treatment of ITP With Rituximab and / or Accutane

Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China

Detailed description

This is a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China. The investigators explore the efficacy and safety of Rituximab plus short-term methylprednisolone compare standard dose methylprednisolone in newly diagnosed ITP participants.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Rituximab plus methylprednisolone	rituximab （1000mg IV day1, week 3, week 17 , and week 19）
DRUG	methylprednisolone	1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2016-05-02
• Last updated: 2016-05-13