Clinical trial NCT01255332: Helicobacter Pylori Immune Thrombocytopenic Purpura
Official title: Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Thrombocytopenic Purpura
Keywords: ITP
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2010-12-07
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: immune thrombocytopenic purpura

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

Eligibility 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

Primary outcomes:
measure: Overall response
timeFrame: 2 years
Secondary outcomes:
measure: Eradication rate of H. pylori
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Asanbyeongwon-gil, songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Jung-Hee Lee, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Hallym University Sacred Heart Hospital
name: Hyo Jung Kim, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.