Helicobacter Pylori Immune Thrombocytopenic Purpura (HpyloriITP)

Cooperative Study Group A for Hematology

Status: Unknown

Conditions: Immune Thrombocytopenic Purpura

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01255332

C-023

Details and patient eligibility

About

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.

Full 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

Enrollment: 26 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No 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

Trial design

26 participants in 1 patient group

C13-urea breath test: positive

Description:

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