MedDataX Logo

Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

NCT ID: NCT01730352

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune Thrombocytopenic Purpura Helicobacter Pylori Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

immune thrombocytopenic purpura chronic immune thrombocytopenic purpura secondary immune thrombocytopenic purpura Helicobacter pylori infection Helicobacter pylori gastritis children adolescents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

H. pylori no treatment

Observational group, with clinical and platelet count follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

H. pylori triple therapy

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.

Group Type EXPERIMENTAL

H. pylori triple therapy

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

H. pylori triple therapy

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Triple therapy for H. pylori H. pylori eradication therapy Pyloripac

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* clinical diagnosis of chronic immune thrombocytopenic purpura
* children and adolescents up to 20 years

Exclusion Criteria

* known hypersensitivity to any of the drugs
* recent treatment for H. pylori eradication
Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elisabete Kawakami

Professor, PhD MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisabete Kawakami, Professor

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Irmandade da Santa Casa de Misericordia se Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Centro de Hematologia de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Hospital Estadual Infantil Darcy Vargas

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08/56706-0

Identifier Type: -

Identifier Source: org_study_id