H. Pylori Eradication for Moderate ITP

Phase 3

• Conditions: Helicobacter Pylori; Immune Thrombocytopenic Purpura; Immune Thrombocytopenia

• Registration Number: NCT03177629
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-23
• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
overall response rate (ORR: complete response + response rate) of platelets	visit 4 (3 months after randomization)	1. ORR between treatment group with UBT (-) and control group with stage 1; 2. International working group criteria for ITP treatment response will be used for ORR definition

Secondary Outcome Measures

Name	Time	Method
ORR between treatment group and control group with stage 1	visit 4 (3 months after randomization)	all patients in the treatment group (with UBT (+) or UBT (-) patients)
ORR of control group with stage 2	At visit 5 (6 months after randomization)	patients in the control group with stage 2 with UBT (-)
ORR after H. pylori eradication in all patients who were treated and UBT (-)	3 months after H. pylori eradication	UBT (-) patients in treatment group and control group with stage 2
Time to response	from initiation date of study drugs to the date of R or CR (assessed up to 6 months)	from initiation date of study drugs to the date of R or CR in treatment group
Response duration	from the date of R or CR to the date of loss of R or CR / or till last f/u date, whichever came first (assessed up to 6 months)	from the date of R or CR to the date of loss of R or CR / or till last f/u date in treatment group
H. pylori eradication rate	at vist 4 (3 months after randomization) after drug treatment	defined by UBT (-)
drug toxicity and compliance	At visit 2, 3, 4, 5 (1, 2, 3, 6 months after randomization, respectively) for treatment group, at visit 5 (6 months after randomization) for control group stage 2	NCI CTCAE v4.0 for safety measurement, 85% of taking medicine for criteria of compliance
QoL	At visit 1(Day 1 of study drug medication) & vist 4 (3 months after randomization)	within \& between group after H. pylori eradication, FACIT-F, FACIT-Th6
platelet level at randomization	3 months after H. pylori eradication	comparison of platelet level at randomization between treatment responder and non-responder of H. pylori eradication
ITP duration before randomization	3 months after H. pylori eradication	comparison of ITP duration before randomization between treatment responder and non-responder of H. pylori eradication

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of