Helicobacter Pylori Immune Thrombocytopenic Purpura

• Conditions: Immune Thrombocytopenic Purpura

• Registration Number: NCT01255332
• Lead Sponsor: Cooperative Study Group A for Hematology

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 eradication treatment is revealed effective on ITP patients with more than 30X109/L of platelet, it would be valuable treatment especially for young ITP patients with mild to moderate thrombocytopenia.

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 eradication

Study Timeline

• Study Start: 2010-09
• Status Verified: 2010-11
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-12-06
• Last Update Submitted: 2010-12-06
• Study First Posted: 2010-12-07
• Last Update Posted: 2010-12-07
• Primary Completion: 2011-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response	2 years	Overall response rate at 3 months after treatment

Secondary Outcome Measures

Name	Time	Method
Eradication rate of H. pylori	2 years	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.; * Duration of response; * Side effect and safety of treatment

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of