Helicobacter Pylori, Immune Thrombocytopenia, Immune Thrombocytopenic Purpura
Conditions
Keywords
Immune Thrombocytopenic Purpura, Helicobacter pylori
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.
Interventions
DRUGtreatment : 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
Sponsors
Hallym University Medical Center
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactSoo-Me Bang, M.D.
Backup ContactHYO JUNG KIM, M.D.
Outcome results
None listed