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
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Condition or disease | Intervention/treatment | Phase |
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Thrombocytopenia | Other: Steroid refractory ITP | Phase 2 |
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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 |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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)
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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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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

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, professor | 82-53-650-4388 | sunghwa@cu.ac.kr |
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 redpin75@paran.com |
Principal Investigator: | Jung-Hee Lee, professor | Asan Medical Center |
Responsible Party: | COSAH, Cooperative Study Group A for Hematology |
ClinicalTrials.gov Identifier: | NCT01162941 |
Other Study ID Numbers: |
C-019 |
First Posted: | July 15, 2010 Key Record Dates |
Last Update Posted: | July 15, 2010 |
Last Verified: | July 2010 |
ITP |
Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Platelet Disorders Hematologic Diseases Purpura, Thrombocytopenic Purpura Blood Coagulation Disorders Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases |
Hemorrhage Pathologic Processes Skin Manifestations Prednisolone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |