Immune Thrombocytopenic PurpuraPhase 2/3NCT01730352
Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients
A Phase 2/3 study testing H. pylori triple therapy in people with Immune Thrombocytopenic Purpura and Helicobacter Pylori Infection, run by Federal University of São Paulo at 4 sites in Brazil.
Trial summary
The purpose of this study is to determine whether eradication of Helicobacter pylori infection is effective in the improvement of platelet counts in children and adolescents with chronic ITP. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Immune Thrombocytopenic Purpura, Helicobacter Pylori Infection
- What is being tested?
- H. pylori triple therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesBrazil
- Study dates
- Oct 2008to Mar 2012
- Phase
- Phase 2/3
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of chronic immune thrombocytopenic purpura
- children and adolescents up to 20 years
Who cannot join
- known hypersensitivity to any of the drugs
- recent treatment for H. pylori eradication
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Irmandade da Santa Casa de Misericordia se Sao Paulo
São Paulo, São Paulo, 01221-020
Centro de Hematologia de Sao Paulo
São Paulo, São Paulo, 01401-000
Federal University of Sao Paulo
São Paulo, São Paulo, 04021-001
Hospital Estadual Infantil Darcy Vargas
São Paulo, São Paulo, 05614-040
About this study
Official title: Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial
The purpose of this study is to determine whether eradication of Helicobacter pylori infection is effective in the improvement of platelet counts in children and adolescents with chronic ITP.
Read the detailed description
Helicobacter pylori infection has been associated with Immune Thrombocytopenic Purpura (ITP), and there is scientific evidence for the investigation and treatment of this bacterium for adult patients with ITP. However, in children this causal association is not clear, with few published studies.
- Being tested
- H. pylori triple therapy
- Keywords
- immune thrombocytopenic purpura, chronic immune thrombocytopenic purpura, secondary immune thrombocytopenic purpura, Helicobacter pylori infection, Helicobacter pylori gastritis, children, adolescents
- 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.
H. pylori triple therapyDrug
Also called Triple therapy for H. pylori, H. pylori eradication therapy, Pyloripac
Children up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to swallow tablets or capsules, above 30kg: clarithromycin 500mg, amoxicillin 500mg, furazolidone 200mg, and/ or doxycycline 100mg, all 2 times per day, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| H. pylori no treatment | No intervention | Observational group, with clinical and platelet count follow-up |
| H. pylori triple therapy | Experimental | Triple therapy for H. pylori eradication: clarithromycin 15mg/kg, amoxicillin 50mg/kg, furazolidone 7mg/kg and/ or doxycycline 4,4mg/kg (all 2 times per day), with a proton pump inhibitor for 14 days. Receives: Drug: H. pylori triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet response
Responders: Complete Response (CR), persistent elevation of platelet count to >150×109/L; Partial Response (PR), elevation between 20 and 30×109/L above the baseline values, but between 50 and 149×109/L; No Responders: any of the above categories.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Elisabete Kawakami, Federal University of São Paulo
- Investigators
- Elisabete Kawakami, Professor, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730352
- Sponsor's protocol ID
- 08/56706-0
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01730352
- Acronym / sponsor ID
- 08/56706-0
- Keywords
- immune thrombocytopenic purpura, chronic immune thrombocytopenic purpura, secondary immune thrombocytopenic purpura, Helicobacter pylori infection, Helicobacter pylori gastritis, children, adolescents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether eradication of Helicobacter pylori infection is effective in the improvement of platelet counts in children and adolescents with chronic ITP.
Detailed description
Helicobacter pylori infection has been associated with Immune Thrombocytopenic Purpura (ITP), and there is scientific evidence for the investigation and treatment of this bacterium for adult patients with ITP. However, in children this causal association is not clear, with few published studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H. pylori no treatment | No intervention | –Observational group, with clinical and platelet count follow-up |
| H. pylori triple therapy | Experimental | Drug: H. pylori triple therapyTriple therapy for H. pylori eradication: clarithromycin 15mg/kg, amoxicillin 50mg/kg, furazolidone 7mg/kg and/ or doxycycline 4,4mg/kg (all 2 times per day), with a proton pump inhibitor for 14 days. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of chronic immune thrombocytopenic purpura
- children and adolescents up to 20 years
Key exclusion criteria (2 listed)
- known hypersensitivity to any of the drugs
- recent treatment for H. pylori eradication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H. pylori triple therapyAlso: Triple therapy for H. pylori, H. pylori eradication therapy, PyloripacChildren up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to swallow tablets or capsules, above 30kg: clarithromycin 500mg, amoxicillin 500mg, furazolidone 200mg, and/ or doxycycline 100mg, all 2 times per day, for 14 days. | Drug | H. pylori triple therapy |
Primary outcome
platelet response
Time frame: 1 year
Responders: Complete Response (CR), persistent elevation of platelet count to >150×109/L; Partial Response (PR), elevation between 20 and 30×109/L above the baseline values, but between 50 and 149×109/L; No Responders: any of the above categories.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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RecruitingPhase 3
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RecruitingPhase 2
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RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabete Kawakami, Professor principal investigator
Federal University of São Paulo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing H. pylori triple therapy in people with Immune Thrombocytopenic Purpura and Helicobacter Pylori Infection, run by Federal University of São Paulo at 4 sites in Brazil.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2012.