Status:
UNKNOWN
Helicobacter Pylori Immune Thrombocytopenic Purpura
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
20-55 years
Brief Summary
We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. If this e...
Detailed Description
lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days. (Jeil Pharm. CO. LTD. will provide lansoprazole.) C13-UBT, at 4 weeks after onset of treatment, to determine erad...
Eligibility Criteria
Inclusion
- 20\~55 years old
- Persistent or chronic ITP patients, defined by international working group ( persistent: between 3 to 12 months from diagnosis, chronic: lasting for more than 12 months)
- 30X109/L ≤ platelet count ≤ 70X109/L
- C13-urea breath test: positive
- no previous ITP treatment
- no previous H. pylori eradication treatment
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion
- Patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, liver disease, definite SLE, drug, MDS, leukemia
- Uncontrolled hypothyroidism or hyperthyroidism
- Acute active bleeding or infection
- Who taking anti-coagulant or aspirin
- Patients with penicillin allergy
- Patients with side effects of macrolide.
- Patients who taking Mizolastine, Terfenadine, Cisapride, Pimozide, Astemizole, Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine), Bepridil, or Atazanavir
- Patients who have known allergy or severe side effect on study drugs
- Pregnant or lactating women
- Clinically relevant hepatic or renal disease (Creatinine clearance ≤ 30mL/min)
- patients who cannot understand informed consent or express his/her condition
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01255332
Start Date
September 1 2010
End Date
August 1 2012
Last Update
December 7 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea, 138-736