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Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Elisabete Kawakami, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01730352
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: November 2012

November 15, 2012
November 20, 2012
October 2008
May 2011   (final data collection date for primary outcome measure)
platelet response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01730352 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients
Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Immune Thrombocytopenic Purpura
  • Helicobacter Pylori Infection
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
  • 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.
    Intervention: Drug: H. pylori triple therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2012
May 2011   (final data collection date for primary outcome measure)

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
Both
up to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01730352
08/56706-0
Yes
Elisabete Kawakami, Federal University of São Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Elisabete Kawakami, Professor Federal University of Sao Paulo
Federal University of São Paulo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP