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

Phase 2

• Conditions: Thrombocytopenia
• Interventions: Other: Steroid refractory ITP

• Registration Number: NCT01162941
• Lead Sponsor: Cooperative Study Group A for Hematology

Brief Summary

Proportion who would avoid splenectomy at 6 months of follow up

Detailed Description

1. 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.

2. Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)

3. 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 Timeline

• Study Start: 2010-02
• Status Verified: 2010-07
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Last Update Submitted: 2010-07-14
• Study First Posted: 2010-07-15
• Last Update Posted: 2010-07-15
• Primary Completion: 2011-07
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Steroid dependant ITP	Steroid refractory 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)

Primary Outcome Measures

Name	Time	Method
Proportion who would avoid splenectomy at 6 months of follow up	2years	Proportion who would avoid splenectomy at 6 months of follow up

Secondary Outcome Measures

Name	Time	Method
SR,IR	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of