Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

Phase 2

Completed

• Conditions: Immune Thrombocytopenic Purpura; Helicobacter Pylori Infection
• Interventions: Drug: H. pylori triple therapy

• Registration Number: NCT01730352
• Lead Sponsor: Federal University of São Paulo

Brief 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.

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2011-05
• Study Completion: 2012-03
• Status Verified: 2012-11
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-20
• Last Update Submitted: 2012-11-20
• Study First Posted: 2012-11-21
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
H. pylori triple therapy	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.

Primary Outcome Measures

Name	Time	Method
platelet response	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.

Trial Locations

Locations (4)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Centro de Hematologia de Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Irmandade da Santa Casa de Misericordia se Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Hospital Estadual Infantil Darcy Vargas; 🇧🇷 Sao Paulo, Brazil