H. Pylori Eradication for Moderate ITP

Immune Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177629
• Other study ID #: KSH_ITP1701
• Status: Recruiting
• Phase: Phase 3
• Start date: May 23, 2017
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: Soo-Me Bang, M.D.
• Phone: 82 31 787 7039
• Email: smbang7[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori
• Immune Thrombocytopenia
• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• treatment : 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate (ORR: complete response + response rate) of platelets	ORR between treatment group with UBT (-) and control group with stage 1; International working group criteria for ITP treatment response will be used for ORR definition	visit 4 (3 months after randomization)
Secondary	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)
Secondary	ORR of control group with stage 2	patients in the control group with stage 2 with UBT (-)	At visit 5 (6 months after randomization)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	H. pylori eradication rate	defined by UBT (-)	at vist 4 (3 months after randomization) after drug treatment
Secondary	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
Secondary	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)
Secondary	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
Secondary	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