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Immune Thrombocytopenic PurpuraPhase 3NCT03177629

H. Pylori Eradication for Moderate ITP

A Phase 3 study testing treatment : H. pylori eradication in people with Immune Thrombocytopenic Purpura and Helicobacter Pylori, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
treatment : H. pylori eradication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteSouth Korea
Study dates
23 May 2017to Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Soo-Me Bang, M.D. contact

82 31 787 7039

smbang7@snu.ac.kr

HYO JUNG KIM, M.D. contact

82 31 380 3704

hemonc@hallym.or.kr

South Korea1 site, 1 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

    Soo-Mee Bang, M.D., 82 31 787 7039, smbang7@snu.ac.kr

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
treatment : H. pylori eradication
Keywords
Immune Thrombocytopenic Purpura, Helicobacter pylori
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • treatment : H. pylori eradicationDrug

    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

Study groups in NCT03177629
Study groupRoleWhat they receive
Treatment arm: H. pylori eradicationExperimentaltreatment arm: H. pylori eradication at visit 1(0 month)
Receives: Drug: treatment : H. pylori eradication
Control arm -1st stageNo interventionAt visit 1(0 month) no intervention, observation only from visit 1 to visit 3
Control arm - 2nd stageActive comparatorSame 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).
Receives: Drug: treatment : H. pylori eradication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate (ORR: complete response + response rate) of platelets

    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

    Measured: visit 4 (3 months after randomization)

Secondary outcomes (10)

  1. ORR between treatment group and control group with stage 1

    all patients in the treatment group (with UBT (+) or UBT (-) patients)

    Measured: visit 4 (3 months after randomization)

  2. ORR of control group with stage 2

    patients in the control group with stage 2 with UBT (-)

    Measured: At visit 5 (6 months after randomization)

  3. ORR after H. pylori eradication in all patients who were treated and UBT (-)

    UBT (-) patients in treatment group and control group with stage 2

    Measured: 3 months after H. pylori eradication

  4. Time to response

    from initiation date of study drugs to the date of R or CR in treatment group

    Measured: from initiation date of study drugs to the date of R or CR (assessed up to 6 months)

  5. Response duration

    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

    Measured: 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)

  6. H. pylori eradication rate

    defined by UBT (-)

    Measured: at vist 4 (3 months after randomization) after drug treatment

  7. drug toxicity and compliance

    NCI CTCAE v4.0 for safety measurement, 85% of taking medicine for criteria of compliance

    Measured: 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

  8. QoL

    within \& between group after H. pylori eradication, FACIT-F, FACIT-Th6

    Measured: At visit 1(Day 1 of study drug medication) & vist 4 (3 months after randomization)

  9. platelet level at randomization

    comparison of platelet level at randomization between treatment responder and non-responder of H. pylori eradication

    Measured: 3 months after H. pylori eradication

  10. ITP duration before randomization

    comparison of ITP duration before randomization between treatment responder and non-responder of H. pylori eradication

    Measured: 3 months after H. pylori eradication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2017
  2. Study start23 May 2017
  3. Primary completionJun 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03177629
Sponsor's protocol ID
KSH_ITP1701
Status last verified
Sep 2018
First submitted
29 May 2017
Last updated
7 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25501820

  • Han B, Kim HJ, Yhim HY, Oh D, Bae SH, Shin HJ, Lee WS, Kwon J, Lee JO, Kim HJ, Bang SM. Sequential eradication of Helicobacter pylori as a treatment for immune thrombocytopenia in patients with moderate thrombocytopenia: a multicenter prospective randomized phase 3 study. Ann Hematol. 2022 Jul;101(7):1435-1445. doi: 10.1007/s00277-022-04782-2. Epub 2022 May 28.

    PubMed 35643952

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing treatment : H. pylori eradication in people with Immune Thrombocytopenic Purpura and Helicobacter Pylori, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Soo-Me Bang, M.D. (82 31 787 7039, smbang7@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (ORR: complete response + response rate) of platelets (time frame: visit 4 (3 months after randomization)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03177629, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.

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