H. Pylori Eradication for Moderate ITP

Seoul National University

Status and phase: Unknown; Phase 3

Conditions: Immune Thrombocytopenia; Immune Thrombocytopenic Purpura; Helicobacter Pylori

Treatments: Drug: treatment : H. pylori eradication

Study type: Interventional

Funder types: Other

Identifiers

NCT03177629

KSH_ITP1701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Treatment arm: H. pylori eradication

Experimental group

Description:

treatment arm: H. pylori eradication at visit 1(0 month)

Treatment:

Drug: treatment : H. pylori eradication

Control arm -1st stage

No Intervention group

Description:

At visit 1(0 month) no intervention, observation only from visit 1 to visit 3

Control arm - 2nd stage

Active Comparator group

Description:

Same patients group with control arm 1st stage. After observation for 3 months during stage 1, the patients of control arm will be treated with same regimen for H. pylori eradication at visit 4 (2nd stage).

Treatment:

Drug: treatment : H. pylori eradication