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
Recruitment status was Recruiting
Sponsor:
Cooperative Study Group A for Hematology
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
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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.
| 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
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 May 22, 2013