Clinical trial NCT03177629: H. Pylori Eradication for Moderate ITP
Official title: Efficacy of Helicobacter Pylori Eradication for the Treatment of Chronic or Persistent Immune Thrombocytopenic Purpura Patients With Moderate Thrombocytopenia: Multicenter Prospective Randomized Phase 3 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Immune Thrombocytopenic Purpura
Helicobacter Pylori
Immune Thrombocytopenia
Keywords: Immune Thrombocytopenic Purpura
Helicobacter pylori
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University Medical Center
First posted: 2017-06-06
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: overall response rate (ORR: complete response + response rate) of platelets
timeFrame: visit 4 (3 months after randomization)
Secondary outcomes:
measure: ORR between treatment group and control group with stage 1
timeFrame: visit 4 (3 months after randomization)
measure: ORR of control group with stage 2
timeFrame: At visit 5 (6 months after randomization)
measure: ORR after H. pylori eradication in all patients who were treated and UBT (-)
timeFrame: 3 months after H. pylori eradication
measure: Time to response
timeFrame: from initiation date of study drugs to the date of R or CR (assessed up to 6 months)
measure: Response duration
timeFrame: 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)
measure: H. pylori eradication rate
timeFrame: at vist 4 (3 months after randomization) after drug treatment
measure: drug toxicity and compliance
timeFrame: 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
measure: QoL
timeFrame: At visit 1(Day 1 of study drug medication) & vist 4 (3 months after randomization)
measure: platelet level at randomization
timeFrame: 3 months after H. pylori eradication
measure: ITP duration before randomization
timeFrame: 3 months after H. pylori eradication
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo-Me Bang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim H, Lee WS, Lee KH, Bae SH, Kim MK, Joo YD, Zang DY, Jo JC, Lee SM, Lee JH, Lee JH, Kim DY, Ryoo HM, Hyun MS, Kim HJ; CoOperative Study Group A for Hematology (COSAH). Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia. Ann Hematol. 2015 May;94(5):739-46. doi: 10.1007/s00277-014-2268-9. Epub 2014 Dec 13.
citation: Han B, Kim HJ, Yhim HY, Oh D, Bae SH, Shin HJ, Lee WS, Kwon J, Lee JO, Kim HJ, Bang SM. Sequential eradication of Helicobacter pylori as a treatment for immune thrombocytopenia in patients with moderate thrombocytopenia: a multicenter prospective randomized phase 3 study. Ann Hematol. 2022 Jul;101(7):1435-1445. doi: 10.1007/s00277-022-04782-2. Epub 2022 May 28.