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Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

Primary Purpose

Immune Thrombocytopenic Purpura, Helicobacter Pylori Infection

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
H. pylori triple therapy
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura focused on measuring immune thrombocytopenic purpura, chronic immune thrombocytopenic purpura, secondary immune thrombocytopenic purpura, Helicobacter pylori infection, Helicobacter pylori gastritis, children, adolescents

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irmandade da Santa Casa de Misericordia se Sao Paulo
  • Centro de Hematologia de Sao Paulo
  • Federal University of Sao Paulo
  • Hospital Estadual Infantil Darcy Vargas

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

H. pylori no treatment

H. pylori triple therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2012
Last Updated
November 20, 2012
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01730352
Brief Title
Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients
Official Title
Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura, Helicobacter Pylori Infection
Keywords
immune thrombocytopenic purpura, chronic immune thrombocytopenic purpura, secondary immune thrombocytopenic purpura, Helicobacter pylori infection, Helicobacter pylori gastritis, children, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H. pylori no treatment
Arm Type
No Intervention
Arm Description
Observational group, with clinical and platelet count follow-up
Arm Title
H. pylori triple therapy
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
H. pylori triple therapy
Other Intervention Name(s)
Triple therapy for H. pylori, H. pylori eradication therapy, Pyloripac
Intervention Description
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.
Primary Outcome Measure Information:
Title
platelet response
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabete Kawakami, Professor
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade da Santa Casa de Misericordia se Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Centro de Hematologia de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01401-000
Country
Brazil
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04021-001
Country
Brazil
Facility Name
Hospital Estadual Infantil Darcy Vargas
City
Sao Paulo
ZIP/Postal Code
05614-040
Country
Brazil

12. IPD Sharing Statement

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Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

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