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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
History of Changes
  Purpose

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 Intervention Phase
Immune Thrombocytopenic Purpura
Helicobacter Pylori Infection
 Drug: H. pylori triple therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730352

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil, 04021-001
Centro de Hematologia de Sao Paulo
Sao Paulo, Brazil, 01401-000
Hospital Estadual Infantil Darcy Vargas
Sao Paulo, Brazil, 05614-040
Irmandade da Santa Casa de Misericordia se Sao Paulo
Sao Paulo, Brazil, 01221-020
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Elisabete Kawakami, Professor Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Elisabete Kawakami, Professor, PhD MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01730352     History of Changes
Other Study ID Numbers: 08/56706-0
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: Brazil: Agencia Nacional de Vigilancia Sanitaria (ANVISA)

Keywords provided by Federal University of São Paulo:
immune thrombocytopenic purpura
chronic immune thrombocytopenic purpura
secondary immune thrombocytopenic purpura
Helicobacter pylori infection
 Helicobacter pylori gastritis
children
adolescents

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Helicobacter Infections
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
 Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013