Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730352
• Other study ID #: 08/56706-0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 15, 2012
• Last updated: November 20, 2012
• Start date: October 2008
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Agencia Nacional de Vigilancia Sanitaria (ANVISA)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Immune Thrombocytopenic Purpura
• Infection
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Brazil	Centro de Hematologia de Sao Paulo	Sao Paulo
Brazil	Federal University of Sao Paulo	Sao Paulo
Brazil	Hospital Estadual Infantil Darcy Vargas	Sao Paulo
Brazil	Irmandade da Santa Casa de Misericordia se Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No