H. Pylori Eradication for Moderate ITP

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of H. pylori eradication for the treatment of chronic or persistent immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. This is a multi-center, open label, prospective randomized phase IIl study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Hallym University Medical Center

Criteria

Inclusion Criteria:

• Age ≥ 19 years

• Persistent or chronic ITP patients defined by international working group

• 30 X 10^9/L ≤ platelet level ≤ 80 X 10^9/L

• H. pylori infection should be confirmed by at least one of tests: urea breath test (UBT), CLO, stool H. pylori Ag, H. pylori in gastric tissue (reported by a trained pathologist)

• No history of any ITP treatment for the past 3 months

• No previous history of H. pylori eradication treatment

• Patients who voluntarily participate in this study and with informed consents

Exclusion Criteria:

• patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, malignant neoplasm, liver disease, definite SLE and other autoimmune diseases, drugs, MDS and leukemia

• uncontrolled hypothyroidism or hyperthyroidism

• active bleeding for the past 3 months or history of hemorrhagic gastric ulcer or brain hemorrhage

• active infection

• patients who are taking anticoagulant or aspirin

• patients with penicillin allergy or side effects of macrolide

• patients who are taking mizolastine, terfenadine, cisapride, pimozide, astemizole, ergot alkaloid and its derivatives (ergotamine and dihydroergotamine), bepridil or atazanavir

• patients who have known allergy or severe side effect on study drugs

• pregnant or lactating women