H. Pylori Eradication for Moderate ITP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immune Thrombocytopenic Purpura Helicobacter Pylori Immune Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

treatment group vs control group Patients in treatment group will be treated with antibiotics for H. pylori eradication at visit 1.

Control group has 2 stage. Fot the 1st stage (for 3 months), the patient will be observed without any treatment. And at visit 4, at 2nd stage, they will be treated with the same regimen for H. pylori eradication.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm: H. pylori eradication

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

Group Type EXPERIMENTAL

treatment : H. pylori eradication

Intervention Type DRUG

treatment: H. pylori eradication (pantoprazole, amoxicillin, clarithromycin, metronidazole) to treatment group at visit 1 and to control group 2nd stage at visit 4.

Day 1-5: pantoprazole 40mg bid, amoxicillin 1000mg bid, PO Day 6 - 10: pantoprazole 40mg bid, clarithromycin 500mg bid, metronidazole 500mg tid, PO

Control arm -1st stage

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Control arm - 2nd stage

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).

Group Type ACTIVE_COMPARATOR

treatment : H. pylori eradication

Intervention Type DRUG

treatment: H. pylori eradication (pantoprazole, amoxicillin, clarithromycin, metronidazole) to treatment group at visit 1 and to control group 2nd stage at visit 4.

Day 1-5: pantoprazole 40mg bid, amoxicillin 1000mg bid, PO Day 6 - 10: pantoprazole 40mg bid, clarithromycin 500mg bid, metronidazole 500mg tid, PO

Interventions

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treatment : H. pylori eradication

treatment: H. pylori eradication (pantoprazole, amoxicillin, clarithromycin, metronidazole) to treatment group at visit 1 and to control group 2nd stage at visit 4.

Day 1-5: pantoprazole 40mg bid, amoxicillin 1000mg bid, PO Day 6 - 10: pantoprazole 40mg bid, clarithromycin 500mg bid, metronidazole 500mg tid, PO

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No