For Healthcare Professionals

Helicobacter Pylori Immune Thrombocytopenic Purpura

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. 20~55 years old
  2. 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)
  3. 30X109/L ≤ platelet count ≤ 70X109/L
  4. C13-urea breath test: positive
  5. no previous ITP treatment
  6. no previous H. pylori eradication treatment
  7. 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

  1. Patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, liver disease, definite SLE, drug, MDS, leukemia
  2. Uncontrolled hypothyroidism or hyperthyroidism
  3. Acute active bleeding or infection
  4. Who taking anti-coagulant or aspirin
  5. Patients with penicillin allergy
  6. Patients with side effects of macrolide.
  7. Patients who taking Mizolastine, Terfenadine, Cisapride, Pimozide, Astemizole, Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine), Bepridil, or Atazanavir
  8. Patients who have known allergy or severe side effect on study drugs
  9. Pregnant or lactating women
  10. Clinically relevant hepatic or renal disease (Creatinine clearance ≤ 30mL/min)
  11. patients who cannot understand informed consent or express his/her condition
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 82-31-380-3859Email iconEmail Study Center

Study’s details


Contition

Immune Thrombocytopenic Purpura

Age (in years)

20 - 55

Phase

Phase 2

Participants needed

26

Est. Completion Date

Aug 2012

Treatment type

Observational


Sponsor

Cooperative Study Group A for Hematology

ClinicalTrials.gov identifier

NCT01255332

Study number

C023

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