H. Pylori Eradication for Moderate ITP

Last updated: September 5, 2018
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Thrombosis

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT03177629
KSH_ITP1701
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 trainedpathologist)

  • 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

Exclusion Criteria:

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

  • uncontrolled hypothyroidism or hyperthyroidism

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

  • 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 oratazanavir

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

  • pregnant or lactating women

Study Design

Total Participants: 54
Study Start date:
May 23, 2017
Estimated Completion Date:
December 31, 2020

Study Description

Current treatment guideline of ITP recommends corticosteroid as the first line treatment when patient has active bleeding or less than 30×10^9/L of platelet, because of side effect and cost issues. Since the first case report by Italian study, several investigators have reported that secondary immune thrombocytopenia (ITP) can occur in patients with Helicobacter pylori (H. pylori) infection. We already reported the efficacy of H. pylori eradication in moderate ITP patients with phase II study (Annals Hematology 2015:94:739-46). To improve the evidence of this strategy for the treatment of moderate ITP, we plan to start this multi-center, open label, prospective randomized phase 3 study.

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 463-707
    Korea, Republic of

    Active - Recruiting

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