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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGoverall response rate (ORR: complete response + response rate) of platelets
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
Time frame: visit 4 (3 months after randomization)
ORR between treatment group and control group with stage 1
all patients in the treatment group (with UBT (+) or UBT (-) patients)
Time frame: visit 4 (3 months after randomization)
ORR of control group with stage 2
patients in the control group with stage 2 with UBT (-)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (-)
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months after H. pylori eradication