Helicobacter Pylori Immune Thrombocytopenic Purpura

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

Sponsors

Lead Sponsor: Cooperative Study Group A for Hematology

Source Cooperative Study Group A for Hematology
Brief Summary

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

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

Overall Status Unknown status
Start Date September 2010
Completion Date August 2012
Primary Completion Date August 2011
Study Type Observational
Primary Outcome
Measure Time Frame
Overall response 2 years
Secondary Outcome
Measure Time Frame
Eradication rate of H. pylori 2 years
Enrollment 26
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Hyo Jung Kim, professor

Phone: 82-31-380-3859

Email: [email protected]

Location
Facility: Status: Contact: Asan Medical Center Yae-Eun Jang, nurse 82-2-3010-6378 [email protected]
Location Countries

Korea, Republic of

Verification Date

November 2010

Responsible Party

Name Title: COSAH

Organization: Cooperative Study Group A for Hematology

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: C13-urea breath test: positive

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

Acronym HpyloriITP
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov