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

Primary Purpose

Thrombocytopenia

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Steroid refractory ITP
Sponsored by
Cooperative Study Group A for Hematology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Steroid dependant ITP

Arm Description

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)

Outcomes

Primary Outcome Measures

Proportion who would avoid splenectomy at 6 months of follow up
Proportion who would avoid splenectomy at 6 months of follow up

Secondary Outcome Measures

SR,IR
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

Full Information

First Posted
July 14, 2010
Last Updated
July 14, 2010
Sponsor
Cooperative Study Group A for Hematology
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1. Study Identification

Unique Protocol Identification Number
NCT01162941
Brief Title
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Official Title
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Cooperative Study Group A for Hematology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Proportion who would avoid splenectomy at 6 months of follow up
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
ITP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steroid dependant ITP
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Steroid refractory ITP
Other Intervention Name(s)
prednisolone 1mg/kg
Intervention Description
a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
Primary Outcome Measure Information:
Title
Proportion who would avoid splenectomy at 6 months of follow up
Description
Proportion who would avoid splenectomy at 6 months of follow up
Time Frame
2years
Secondary Outcome Measure Information:
Title
SR,IR
Description
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
Time Frame
2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-Hwa Bae, professor
Phone
82-53-650-4388
Email
sunghwa@cu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hee Lee, professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Asanbyeongwon-gil, songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yae-Eun Jang, nurse
Phone
82-2-3010-6378
Email
redpin75@paran.com

12. IPD Sharing Statement

Links:
URL
http://www.google.co.kr
Description
Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP)

Learn more about this trial

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

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