Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Study Overview
=================
Brief Summary
-----------------
Proportion who would avoid splenectomy at 6 months of follow up

Detailed Description
-----------------
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.

Official Title
-----------------
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Conditions
-----------------
Thrombocytopenia

Intervention / Treatment
-----------------
* Other: Steroid refractory ITP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.ITP is defined by (a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia 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: 1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug 2.Pregnancy 3.Splectomized patients 4.Rh- blood type 5.Hemoglobin < 10g/dL 6.Known hypersensitivity to immunoglobulins 7.A positive direct antiglobulin test 8.Clinically relevant hepatic or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroid dependant ITP<br>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<br>* a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)<br>* Other names: prednisolone 1mg/kg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ITP