A Phase 2/3 interventional study of H. pylori triple therapy in Immune Thrombocytopenic Purpura and Helicobacter Pylori Infection, sponsored by Federal University of São Paulo. Completed at 4 sites in Brazil. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2012-11-21.
Sponsored by Federal University of São Paulo · Phase 2/3, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Observational group, with clinical and platelet count follow-up
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.
Also known as: Triple therapy for H. pylori, H. pylori eradication therapy, Pyloripac
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.
Time frame: 1 year
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo