Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

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.

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Key information

Conditions

Immune Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Helicobacter Pylori Infection Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centro de Hematologia de Sao Paulo, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

H. pylori triple therapy

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.

Other names: Triple therapy for H. pylori, H. pylori eradication therapy, Pyloripac

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Nov 21, 2012
Registry last updated: Nov 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed