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

November 24, 2010
December 6, 2010
September 2010
August 2011   (final data collection date for primary outcome measure)
Overall response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Overall response rate at 3 months after treatment
Same as current
Complete list of historical versions of study NCT01255332 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Helicobacter Pylori Immune Thrombocytopenic Purpura
Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

immune thrombocytopenic purpura

Immune Thrombocytopenic Purpura
Not Provided
C13-urea breath test: positive
lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
August 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 55 Years
No
Contact: Hyo Jung Kim, professor 82-31-380-3859 hemonc@hallym.or.kr
Korea, Republic of
 
NCT01255332
C-023
Yes
COSAH, Cooperative Study Group A for Hematology
Cooperative Study Group A for Hematology
Not Provided
Principal Investigator: Jung-Hee Lee, professor Asan Medical Center
Principal Investigator: Hyo Jung Kim, professor Department of Internal Medicine, Hallym University Sacred Heart Hospital
Cooperative Study Group A for Hematology
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP