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Trial record 6 of 6 for:    "Thrombocytopenic Purpura, Autoimmune" | "Amoxicillin"

H. Pylori Eradication for Moderate ITP

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ClinicalTrials.gov Identifier: NCT03177629
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Hallym University Medical Center
Information provided by (Responsible Party):
Soo-Mee Bang, Seoul National University Hospital

Brief Summary:
The purpose of this study is to determine the efficacy of H. pylori eradication for the treatment of chronic or persistent immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. This is a multi-center, open label, prospective randomized phase IIl study.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Helicobacter Pylori Immune Thrombocytopenia Drug: treatment : H. pylori eradication Phase 3

Detailed Description:
Current treatment guideline of ITP recommends corticosteroid as the first line treatment when patient has active bleeding or less than 30×10^9/L of platelet, because of side effect and cost issues. Since the first case report by Italian study, several investigators have reported that secondary immune thrombocytopenia (ITP) can occur in patients with Helicobacter pylori (H. pylori) infection. We already reported the efficacy of H. pylori eradication in moderate ITP patients with phase II study (Annals Hematology 2015:94:739-46). To improve the evidence of this strategy for the treatment of moderate ITP, we plan to start this multi-center, open label, prospective randomized phase 3 study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

treatment group vs control group Patients in treatment group will be treated with antibiotics for H. pylori eradication at visit 1.

Control group has 2 stage. Fot the 1st stage (for 3 months), the patient will be observed without any treatment. And at visit 4, at 2nd stage, they will be treated with the same regimen for H. pylori eradication.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Helicobacter Pylori Eradication for the Treatment of Chronic or Persistent Immune Thrombocytopenic Purpura Patients With Moderate Thrombocytopenia: Multicenter Prospective Randomized Phase 3 Study
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Treatment arm: H. pylori eradication
treatment arm: H. pylori eradication at visit 1(0 month)
Drug: treatment : H. pylori eradication

treatment: H. pylori eradication (pantoprazole, amoxicillin, clarithromycin, metronidazole) to treatment group at visit 1 and to control group 2nd stage at visit 4.

Day 1-5: pantoprazole 40mg bid, amoxicillin 1000mg bid, PO Day 6 - 10: pantoprazole 40mg bid, clarithromycin 500mg bid, metronidazole 500mg tid, PO


No Intervention: Control arm -1st stage
At visit 1(0 month) no intervention, observation only from visit 1 to visit 3
Active Comparator: Control arm - 2nd stage
Same patients group with control arm 1st stage. After observation for 3 months during stage 1, the patients of control arm will be treated with same regimen for H. pylori eradication at visit 4 (2nd stage).
Drug: treatment : H. pylori eradication

treatment: H. pylori eradication (pantoprazole, amoxicillin, clarithromycin, metronidazole) to treatment group at visit 1 and to control group 2nd stage at visit 4.

Day 1-5: pantoprazole 40mg bid, amoxicillin 1000mg bid, PO Day 6 - 10: pantoprazole 40mg bid, clarithromycin 500mg bid, metronidazole 500mg tid, PO





Primary Outcome Measures :
  1. overall response rate (ORR: complete response + response rate) of platelets [ Time Frame: visit 4 (3 months after randomization) ]
    1. ORR between treatment group with UBT (-) and control group with stage 1
    2. International working group criteria for ITP treatment response will be used for ORR definition


Secondary Outcome Measures :
  1. ORR between treatment group and control group with stage 1 [ Time Frame: visit 4 (3 months after randomization) ]
    all patients in the treatment group (with UBT (+) or UBT (-) patients)

  2. ORR of control group with stage 2 [ Time Frame: At visit 5 (6 months after randomization) ]
    patients in the control group with stage 2 with UBT (-)

  3. ORR after H. pylori eradication in all patients who were treated and UBT (-) [ Time Frame: 3 months after H. pylori eradication ]
    UBT (-) patients in treatment group and control group with stage 2

  4. Time to response [ Time Frame: from initiation date of study drugs to the date of R or CR (assessed up to 6 months) ]
    from initiation date of study drugs to the date of R or CR in treatment group

  5. Response duration [ Time Frame: from the date of R or CR to the date of loss of R or CR / or till last f/u date, whichever came first (assessed up to 6 months) ]
    from the date of R or CR to the date of loss of R or CR / or till last f/u date in treatment group

  6. H. pylori eradication rate [ Time Frame: at vist 4 (3 months after randomization) after drug treatment ]
    defined by UBT (-)

  7. drug toxicity and compliance [ Time Frame: At visit 2, 3, 4, 5 (1, 2, 3, 6 months after randomization, respectively) for treatment group, at visit 5 (6 months after randomization) for control group stage 2 ]
    NCI CTCAE v4.0 for safety measurement, 85% of taking medicine for criteria of compliance

  8. QoL [ Time Frame: At visit 1(Day 1 of study drug medication) & vist 4 (3 months after randomization) ]
    within & between group after H. pylori eradication, FACIT-F, FACIT-Th6

  9. platelet level at randomization [ Time Frame: 3 months after H. pylori eradication ]
    comparison of platelet level at randomization between treatment responder and non-responder of H. pylori eradication

  10. ITP duration before randomization [ Time Frame: 3 months after H. pylori eradication ]
    comparison of ITP duration before randomization between treatment responder and non-responder of H. pylori eradication



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 19 years
  • Persistent or chronic ITP patients defined by international working group
  • 30 X 10^9/L ≤ platelet level ≤ 80 X 10^9/L
  • H. pylori infection should be confirmed by at least one of tests: urea breath test (UBT), CLO, stool H. pylori Ag, H. pylori in gastric tissue (reported by a trained pathologist)
  • No history of any ITP treatment for the past 3 months
  • No previous history of H. pylori eradication treatment
  • Patients who voluntarily participate in this study and with informed consents

Exclusion Criteria:

  • patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, malignant neoplasm, liver disease, definite SLE and other autoimmune diseases, drugs, MDS and leukemia
  • uncontrolled hypothyroidism or hyperthyroidism
  • active bleeding for the past 3 months or history of hemorrhagic gastric ulcer or brain hemorrhage
  • active infection
  • patients who are taking anticoagulant or aspirin
  • patients with penicillin allergy or side effects of macrolide
  • patients who are taking mizolastine, terfenadine, cisapride, pimozide, astemizole, ergot alkaloid and its derivatives (ergotamine and dihydroergotamine), bepridil or atazanavir
  • patients who have known allergy or severe side effect on study drugs
  • pregnant or lactating women

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): NCT03177629


Contacts
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Contact: Soo-Me Bang, M.D. 82 31 787 7039 smbang7@snu.ac.kr
Contact: HYO JUNG KIM, M.D. 82 31 380 3704 hemonc@hallym.or.kr

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Soo-Mee Bang, M.D.    82 31 787 7039    smbang7@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Hallym University Medical Center
Investigators
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Principal Investigator: Soo-Me Bang, M.D. Seoul National University Bundang Hospital

Publications:
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Responsible Party: Soo-Mee Bang, Professor, Department of Internal Medicine, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03177629     History of Changes
Other Study ID Numbers: KSH_ITP1701
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Soo-Mee Bang, Seoul National University Hospital:
Immune Thrombocytopenic Purpura
Helicobacter pylori
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases