Back to results

H. Pylori Eradication for Moderate ITP

Primary Purpose

Immune Thrombocytopenic Purpura, Helicobacter Pylori, Immune Thrombocytopenia

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

treatment : H. pylori eradication

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura focused on measuring Immune Thrombocytopenic Purpura, Helicobacter pylori

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Treatment arm: H. pylori eradication

Control arm -1st stage

Control arm - 2nd stage

Arm Description

treatment arm: H. pylori eradication at visit 1(0 month)

At visit 1(0 month) no intervention, observation only from visit 1 to visit 3

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ORR between treatment group and control group with stage 1

all patients in the treatment group (with UBT (+) or UBT (-) patients)

ORR of control group with stage 2

patients in the control group with stage 2 with UBT (-)

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 to response

from initiation date of study drugs to the date of R or CR in treatment group

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

H. pylori eradication rate

defined by UBT (-)

drug toxicity and compliance

NCI CTCAE v4.0 for safety measurement, 85% of taking medicine for criteria of compliance

QoL

within & between group after H. pylori eradication, FACIT-F, FACIT-Th6

platelet level at randomization

comparison of platelet level at randomization between treatment responder and non-responder of H. pylori eradication

ITP duration before randomization

comparison of ITP duration before randomization between treatment responder and non-responder of H. pylori eradication

Full Information

NCT ID

NCT03177629

First Posted

May 29, 2017

Last Updated

September 5, 2018

Sponsor

Seoul National University Hospital

Collaborators

Hallym University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03177629

Brief Title

H. Pylori Eradication for Moderate ITP

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 23, 2017 (Actual)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Hallym University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenic Purpura, Helicobacter Pylori, Immune Thrombocytopenia

Keywords

Immune Thrombocytopenic Purpura, Helicobacter pylori

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm: H. pylori eradication

Arm Type

Experimental

Arm Description

treatment arm: H. pylori eradication at visit 1(0 month)

Arm Title

Control arm -1st stage

Arm Type

No Intervention

Arm Description

At visit 1(0 month) no intervention, observation only from visit 1 to visit 3

Arm Title

Control arm - 2nd stage

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

treatment : H. pylori eradication

Intervention Description

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

Primary Outcome Measure Information:

Title

overall response rate (ORR: complete response + response rate) of platelets

Description

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

Time Frame

visit 4 (3 months after randomization)

Secondary Outcome Measure Information:

Title

ORR between treatment group and control group with stage 1

Description

all patients in the treatment group (with UBT (+) or UBT (-) patients)

Time Frame

visit 4 (3 months after randomization)

Title

ORR of control group with stage 2

Description

patients in the control group with stage 2 with UBT (-)

Time Frame

At visit 5 (6 months after randomization)

Title

ORR after H. pylori eradication in all patients who were treated and UBT (-)

Description

UBT (-) patients in treatment group and control group with stage 2

Time Frame

3 months after H. pylori eradication

Title

Time to response

Description

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)

Title

Response duration

Description

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)

Title

H. pylori eradication rate

Description

defined by UBT (-)

Time Frame

at vist 4 (3 months after randomization) after drug treatment

Title

drug toxicity and compliance

Description

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

Title

QoL

Description

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)

Title

platelet level at randomization

Description

comparison of platelet level at randomization between treatment responder and non-responder of H. pylori eradication

Time Frame

3 months after H. pylori eradication

Title

ITP duration before randomization

Description

comparison of ITP duration before randomization between treatment responder and non-responder of H. pylori eradication

Time Frame

3 months after H. pylori eradication

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Soo-Me Bang, M.D.

Phone

82 31 787 7039

smbang7@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

HYO JUNG KIM, M.D.

Phone

82 31 380 3704

hemonc@hallym.or.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soo-Me Bang, M.D.

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Soo-Mee Bang, M.D.

Phone

82 31 787 7039

smbang7@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25501820

Citation

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.

Results Reference

background

PubMed Identifier

35643952

Citation

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.

Results Reference

derived

Learn more about this trial

H. Pylori Eradication for Moderate ITP

We'll reach out to this number within 24 hrs