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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01730352
Other study ID # 08/56706-0
Secondary ID
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


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
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