Working… Menu
Trial record 4 of 6 for:    "Thrombocytopenic Purpura, Autoimmune" | "Amoxicillin"

Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01730352
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Elisabete Kawakami, Federal University of São Paulo

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : March 2012

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

Primary Outcome Measures :
  1. platelet response [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01730352

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

Layout table for additonal information
Responsible Party: Elisabete Kawakami, Professor, PhD MD, Federal University of São Paulo Identifier: NCT01730352     History of Changes
Other Study ID Numbers: 08/56706-0
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: November 21, 2012
Last Verified: November 2012
Keywords provided by Elisabete Kawakami, Federal University of São Paulo:
immune thrombocytopenic purpura
chronic immune thrombocytopenic purpura
secondary immune thrombocytopenic purpura
Helicobacter pylori infection
Helicobacter pylori gastritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Helicobacter Infections
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Hemorrhagic Disorders
Autoimmune Diseases
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Monoamine Oxidase Inhibitors