Helicobacter Pylori Immune Thrombocytopenic Purpura (HpyloriITP)

December 6, 2010 updated by: Cooperative Study Group A for Hematology

Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia

We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia.

If this eradication treatment is revealed effective on ITP patients with more than 30X109/L of platelet, it would be valuable treatment especially for young ITP patients with mild to moderate thrombocytopenia.

Study Overview

Status

Unknown

Conditions

Immune Thrombocytopenic Purpura

Detailed Description

lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days. (Jeil Pharm. CO. LTD. will provide lansoprazole.) C13-UBT, at 4 weeks after onset of treatment, to determine eradication

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- Asanbyeongwon-gil, songpa-gu
  - Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
    - Recruiting
    - Asan Medical Center
    - Contact:
      
      Yae-Eun Jang, nurse
      
      Phone Number: 82-2-3010-6378
      
      Email: redpin75@paran.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

immune thrombocytopenic purpura

Description

Inclusion Criteria:

20~55 years old
Persistent or chronic ITP patients, defined by international working group ( persistent: between 3 to 12 months from diagnosis, chronic: lasting for more than 12 months)
30X109/L ≤ platelet count ≤ 70X109/L
C13-urea breath test: positive
no previous ITP treatment
no previous H. pylori eradication treatment
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

Patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, liver disease, definite SLE, drug, MDS, leukemia
Uncontrolled hypothyroidism or hyperthyroidism
Acute active bleeding or infection
Who taking anti-coagulant or aspirin
Patients with penicillin allergy
Patients with side effects of macrolide.
Patients who taking Mizolastine, Terfenadine, Cisapride, Pimozide, Astemizole, Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine), Bepridil, or Atazanavir
Patients who have known allergy or severe side effect on study drugs
Pregnant or lactating women
Clinically relevant hepatic or renal disease (Creatinine clearance ≤ 30mL/min)
patients who cannot understand informed consent or express his/her condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
C13-urea breath test: positive lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response Time Frame: 2 years	Overall response rate at 3 months after treatment	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of H. pylori Time Frame: 2 years	We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. Duration of response Side effect and safety of treatment	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cooperative Study Group A for Hematology

Investigators

Principal Investigator: Jung-Hee Lee, professor, Asan Medical Center
Principal Investigator: Hyo Jung Kim, professor, Department of Internal Medicine, Hallym University Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Estimate)