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| Name | Class |
|---|---|
| Hallym University Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm: H. pylori eradication | Experimental | treatment arm: H. pylori eradication at visit 1(0 month) |
|
| Control arm -1st stage | No Intervention | At visit 1(0 month) no intervention, observation only from visit 1 to visit 3 | |
| Control arm - 2nd stage | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment : H. pylori eradication | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR: complete response + response rate) of platelets |
| visit 4 (3 months after randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR between treatment group and control group with stage 1 | all patients in the treatment group (with UBT (+) or UBT (-) patients) | visit 4 (3 months after randomization) |
| ORR of control group with stage 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo-Me Bang, M.D. | Contact | 82 31 787 7039 | smbang7@snu.ac.kr | |
| HYO JUNG KIM, M.D. | Contact | 82 31 380 3704 | hemonc@hallym.or.kr |
| Name | Affiliation | Role |
|---|---|---|
| Soo-Me Bang, M.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25501820 | Background | 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. | |
| 35643952 |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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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.
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|
patients in the control group with stage 2 with UBT (-)
| At visit 5 (6 months after randomization) |
| ORR after H. pylori eradication in all patients who were treated and UBT (-) | UBT (-) patients in treatment group and control group with stage 2 | 3 months after H. pylori eradication |
| Time to response | from initiation date of study drugs to the date of R or CR in treatment group | from initiation date of study drugs to the date of R or CR (assessed up to 6 months) |
| Response duration | 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 | 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) |
| H. pylori eradication rate | defined by UBT (-) | at vist 4 (3 months after randomization) after drug treatment |
| drug toxicity and compliance | NCI CTCAE v4.0 for safety measurement, 85% of taking medicine for criteria of 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 |
| QoL | within & between group after H. pylori eradication, FACIT-F, FACIT-Th6 | At visit 1(Day 1 of study drug medication) & vist 4 (3 months after randomization) |
| platelet level at randomization | comparison of platelet level at randomization between treatment responder and non-responder of H. pylori eradication | 3 months after H. pylori eradication |
| ITP duration before randomization | comparison of ITP duration before randomization between treatment responder and non-responder of H. pylori eradication | 3 months after H. pylori eradication |
| Derived |
| 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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |