Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Information source: Cooperative Study Group A for Hematology
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thrombocytopenia
Intervention: Steroid refractory ITP (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Cooperative Study Group A for Hematology Official(s) and/or principal investigator(s):
Jung-Hee Lee, professor, Principal Investigator, Affiliation: Asan Medical Center
Overall contact:
Sung-Hwa Bae, professor, Phone: 82-53-650-4388, Email: sunghwa@cu.ac.kr
Summary
Proportion who would avoid splenectomy at 6 months of follow up
Clinical Details
Official title: Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion who would avoid splenectomy at 6 months of follow up
Secondary outcome: SR,IR
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sung-Hwa Bae, professor, Phone: 82-53-650-4388, Email: sunghwa@cu.ac.kr
Asan Medical Center, Seoul, Asanbyeongwon-gil, songpa-gu 138-736, Korea, Republic of; Recruiting
Yae-Eun Jang, nurse, Phone: 82-2-3010-6378, Email: redpin75@paran.com
Additional Information
Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP)
Starting date: February 2010
Last updated: July 14, 2010
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