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Helicobacter Pylori Immune Thrombocytopenic Purpura (HpyloriITP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255332
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cooperative Study Group A for Hematology
  Purpose

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 Phase
Immune Thrombocytopenic Purpura Phase 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:
  • Overall response [ Time Frame: 2 years ]
    Overall response rate at 3 months after treatment


Secondary Outcome Measures:
  • Eradication rate of H. pylori [ Time Frame: 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


Estimated Enrollment: 26
Study Start Date: September 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
C13-urea breath test: positive
lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
immune thrombocytopenic purpura
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255332


Contacts
Contact: Hyo Jung Kim, professor 82-31-380-3859 hemonc@hallym.or.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
Contact: Yae-Eun Jang, nurse    82-2-3010-6378    redpin75@paran.com   
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT01255332     History of Changes
Other Study ID Numbers: C-023
First Submitted: November 24, 2010
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
Last Verified: November 2010

Keywords provided by Cooperative Study Group A for Hematology:
ITP

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases