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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
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology

Study Description
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Brief Summary:
Proportion who would avoid splenectomy at 6 months of follow up

Condition or disease Intervention/treatment Phase
Thrombocytopenia Other: Steroid refractory ITP Phase 2

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 Design
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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

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Arms and Interventions
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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)
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


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


Contacts
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Contact: Sung-Hwa Bae, professor 82-53-650-4388 sunghwa@cu.ac.kr

Locations
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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   
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
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Principal Investigator: Jung-Hee Lee, professor Asan Medical Center
More Information
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Additional Information:

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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
Keywords provided by Cooperative Study Group A for Hematology:
ITP
Additional relevant MeSH terms:
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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