Helicobacter Pylori Immune Thrombocytopenic Purpura

NCT ID: NCT01255332

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Immune Thrombocytopenic Purpura

Keywords

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ITP

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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C13-urea breath test: positive

lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cooperative Study Group A for Hematology

NETWORK

Sponsor Role lead

Responsible Party

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Cooperative Study Group A for Hematology

Principal Investigators

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Jung-Hee Lee, professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Hyo Jung Kim, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Hallym University Sacred Heart Hospital

Locations

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Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyo Jung Kim, professor

Role: CONTACT

Phone: 82-31-380-3859

Email: [email protected]

Facility Contacts

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Yae-Eun Jang, nurse

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25501820 (View on PubMed)

Related Links

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http://www.google.co.kr

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

Other Identifiers

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C-023

Identifier Type: -

Identifier Source: org_study_id