H. Pylori Eradication for Moderate ITP

NCT03177629 | Unknown Phase 3

• 1 other identifier: KSH_ITP1701
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenic Purpura; Helicobacter Pylori; Immune Thrombocytopenia

Keywords

Immune Thrombocytopenic Purpura; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• overall 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

  visit 4 (3 months after randomization)

Secondary Outcomes (10)

• ORR between treatment group and control group with stage 1

  visit 4 (3 months after randomization)

• ORR of control group with stage 2

  At visit 5 (6 months after randomization)

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

  3 months after H. pylori eradication

• Time to response

  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, whichever came first (assessed up to 6 months)

Study Arms (3)

Treatment arm: H. pylori eradication

EXPERIMENTAL

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

Drug: treatment : H. pylori eradication

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).

Drug: treatment : H. pylori eradication

Interventions

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

Control arm - 2nd stage; Treatment arm: H. pylori eradication

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years
• Persistent or chronic ITP patients defined by international working group
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hallym University Medical Center: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 25501820 BACKGROUND

• 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.

  PMID: 35643952 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Soo-Me Bang, M.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 6, 2017
• Study Start: May 23, 2017
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)