HpyloriITP: Helicobacter Pylori Immune Thrombocytopenic Purpura

Sponsor

Cooperative Study Group A for Hematology (Other)

Overall Status

Unknown status

CT.gov ID

NCT01255332

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

26 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Overall response [2 years]
Overall response rate at 3 months after treatment

Secondary Outcome Measures

Eradication rate of H. pylori [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Asanbyeongwon-gil, songpa-gu	Korea, Republic of	138-736

Sponsors and Collaborators

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