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Proportion who would avoid splenectomy at 6 months of follow up
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid dependant ITP | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid refractory ITP | Other | a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion who would avoid splenectomy at 6 months of follow up | Proportion who would avoid splenectomy at 6 months of follow up | 2years |
| Measure | Description | Time Frame |
|---|---|---|
| SR,IR | 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 |
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Inclusion Criteria:
1.ITP is defined by
2.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)
3.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)
4.18 years old or more
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung-Hwa Bae, professor | Contact | 82-53-650-4388 | sunghwa@cu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Hee Lee, professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Asanbyeongwon-gil, Songpa-gu | 138-736 | South Korea |
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| Label | URL |
|---|---|
| Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP) | View source |
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|
| 2years |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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