Treatment of ITP With Rituximab and / or Accutane
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|ClinicalTrials.gov Identifier: NCT02757196|
Recruitment Status : Unknown
Verified May 2016 by Peking University People's Hospital.
Recruitment status was: Not yet recruiting
First Posted : May 2, 2016
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Rituximab plus methylprednisolone Drug: methylprednisolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Rituximab plus methylprednisolone
Combination therapy with rituximab （1000mg IV day1, week 3, week 17 , and week 19）plus short-term methylprednisolone (1mg/kg, oral or IV; reduce to 50% of base dose at week 4, then reduce 8mg every 1 week until stopped).
Drug: Rituximab plus methylprednisolone
rituximab （1000mg IV day1, week 3, week 17 , and week 19）
Other Name: monoclone antibody of cluster of differentiation antigen 20
Active Comparator: Methylprednisolone
standard dose methylprednisolone alone (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).
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
Other Name: intravenous methylprednisolone
- Relapse free survival [ Time Frame: From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year ]Relapse was defined as a drop in platelet count to <30 ×109/L following an initial best response (partial or complete response).
- Cumulative response rate [ Time Frame: 1 year ]platelet count ≥ 30 x 10^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.
- Cumulative complete response rate [ Time Frame: 1 year ]platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding
- Cumulative relapse rate [ Time Frame: 1 year ]Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse)
- adverse event/serious adverse event and cumulative rate of bleeding events [ Time Frame: 1 year ]adverse event/serious adverse event associated with study drugs and bleeding events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757196
|Contact: Xiao-Hui Zhang, Doctorfirstname.lastname@example.org|
|Contact: Ru Feng, Doctoremail@example.com|
|Study Chair:||Xiao-jun Huang, Dr||Peking University People's Hospital|