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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Cooperative Study Group A for Hematology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT01162941
First received: July 14, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

July 14, 2010
July 14, 2010
February 2010
July 2011   (final data collection date for primary outcome measure)
Proportion who would avoid splenectomy at 6 months of follow up [ Time Frame: 2years ] [ Designated as safety issue: Yes ]
Proportion who would avoid splenectomy at 6 months of follow up
Same as current
No Changes Posted
SR,IR [ Time Frame: 2years ] [ Designated as safety issue: Yes ]
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
Same as current
Not Provided
Not Provided
 
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Proportion who would avoid splenectomy at 6 months of follow up

  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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thrombocytopenia
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
38
January 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sung-Hwa Bae, professor 82-53-650-4388 sunghwa@cu.ac.kr
Korea, Republic of
 
NCT01162941
C-019
No
COSAH, Cooperative Study Group A for Hematology
Cooperative Study Group A for Hematology
Not Provided
Principal Investigator: Jung-Hee Lee, professor Asan Medical Center
Cooperative Study Group A for Hematology
July 2010

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