Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01730352

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenic Purpura Helicobacter Pylori Infection	Drug: H. pylori triple therapy	Phase 2/Phase 3

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

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: H. pylori no treatment Observational group, with clinical and platelet count follow-up
Experimental: 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.	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. Other Names: Triple therapy for H. pylori H. pylori eradication therapy Pyloripac

Arm

Intervention/Treatment

No Intervention: H. pylori no treatment

Observational group, with clinical and platelet count follow-up

Experimental: 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.

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.

Other Names:

Triple therapy for H. pylori

H. pylori eradication therapy

Pyloripac

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Irmandade da Santa Casa de Misericordia se Sao Paulo	Sao Paulo	Brazil	01221-020
2	Centro de Hematologia de Sao Paulo	Sao Paulo	Brazil	01401-000
3	Federal University of Sao Paulo	Sao Paulo	Brazil	04021-001
4	Hospital Estadual Infantil Darcy Vargas	Sao Paulo	Brazil	05614-040