Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Helicobacter Pylori Immune Thrombocytopenic Purpura (HpyloriITP)

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.
 
ClinicalTrials.gov Identifier: NCT01255332
Recruitment Status : Unknown
Verified November 2010 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology

Tracking Information
First Submitted Date November 24, 2010
First Posted Date December 7, 2010
Last Update Posted Date December 7, 2010
Study Start Date September 2010
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2010)
Overall response [ Time Frame: 2 years ]
Overall response rate at 3 months after treatment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 6, 2010)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Helicobacter Pylori Immune Thrombocytopenic Purpura
Official Title Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia
Brief Summary

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.

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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population immune thrombocytopenic purpura
Condition Immune Thrombocytopenic Purpura
Intervention Not Provided
Study Groups/Cohorts C13-urea breath test: positive
lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days
Publications * Kim H, Lee WS, Lee KH, Bae SH, Kim MK, Joo YD, Zang DY, Jo JC, Lee SM, Lee JH, Lee JH, Kim DY, Ryoo HM, Hyun MS, Kim HJ; CoOperative Study Group A for Hematology (COSAH). Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia. Ann Hematol. 2015 May;94(5):739-46. doi: 10.1007/s00277-014-2268-9. Epub 2014 Dec 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 6, 2010)
26
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2012
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01255332
Other Study ID Numbers C-023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party COSAH, Cooperative Study Group A for Hematology
Study Sponsor Cooperative Study Group A for Hematology
Collaborators Not Provided
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
PRS Account Cooperative Study Group A for Hematology
Verification Date November 2010