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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

Tracking Information
First Submitted Date  ICMJE July 14, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date July 15, 2010
Study Start Date  ICMJE February 2010
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Official Title  ICMJE Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombocytopenia
Intervention  ICMJE 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
Study Arms  ICMJE 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)
Intervention: Other: Steroid refractory ITP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2010)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2012
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162941
Other Study ID Numbers  ICMJE C-019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party COSAH, Cooperative Study Group A for Hematology
Study Sponsor  ICMJE Cooperative Study Group A for Hematology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jung-Hee Lee, professor Asan Medical Center
PRS Account Cooperative Study Group A for Hematology
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP