H. Pylori Eradication for Moderate ITP

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.

Timeline

Start

2017-05-23

Primary completion

2020-06

Completion

2020-12

Outcome

Met primary endpoint

paper Statistically, significant difference in platelet response rates between the two groups were observed (p = 0.017). PMID 35643952 ↗

paper Our study verifies that H. pylori eradication was an effective ITP treatment for patients with H. pylori-associated moderate ITP. PMID 35643952 ↗

Publications

• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amoxicillin	Other / unclassified	1000 mg	Oral
Subject	Clarithromycin	Small molecule	500 mg	Oral
Subject	Metronidazole	Small molecule	500 mg	Oral
Subject	Pantoprazole	Other / unclassified	40 mg	Oral

Indications