Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
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|ClinicalTrials.gov Identifier: NCT01162941|
Recruitment Status : Unknown
Verified July 2010 by Cooperative Study Group A for Hematology.
Recruitment status was: Recruiting
First Posted : July 15, 2010
Last Update Posted : July 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia||Other: Steroid refractory ITP||Phase 2|
If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week.
Second line Helicobacter pylori eradication will be permitted after failure of first line treatment.
- Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)
- Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||January 2012|
Experimental: Steroid dependant ITP
more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)
Other: Steroid refractory ITP
a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
Other Name: prednisolone 1mg/kg
- Proportion who would avoid splenectomy at 6 months of follow up [ Time Frame: 2years ]Proportion who would avoid splenectomy at 6 months of follow up
- SR,IR [ Time Frame: 2years ]Sustained response (platelet count that remained above 30X109/L or 2 folds of initial platelet count at 6 months of follow up) Initial response (an increase in the platelet count of at least 10X109/L or a platelet count of more than 30X109/L by day 7 after the initiation of treatment) Changes of platelet counts Safety of treatment Response rate of HP infected patients Decrement of steroid dose Predictors of response
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): NCT01162941
|Contact: Sung-Hwa Bae, firstname.lastname@example.org|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736|
|Contact: Yae-Eun Jang, nurse 82-2-3010-6378 email@example.com|
|Principal Investigator:||Jung-Hee Lee, professor||Asan Medical Center|