Helicobacter Pylori Immune Thrombocytopenic Purpura (HpyloriITP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Cooperative Study Group A for Hematology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT01255332
First received: November 24, 2010
Last updated: December 6, 2010
Last verified: November 2010
  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 ] [ Designated as safety issue: Yes ]
    Overall response rate at 3 months after treatment


Secondary Outcome Measures:
  • Eradication rate of H. pylori [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT01255332     History of Changes
Other Study ID Numbers: C-023
Study First Received: November 24, 2010
Last Updated: December 6, 2010
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014