Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

NCT01730352 | Completed Phase 2 DMC

• 1 other identifier: 08/56706-0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

H. pylori no treatment

NO INTERVENTION

Observational group, with clinical and platelet count follow-up

H. pylori triple therapy

EXPERIMENTAL

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

Interventions

H. pylori triple therapy DRUG

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

H. pylori triple therapy

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• clinical diagnosis of chronic immune thrombocytopenic purpura
• children and adolescents up to 20 years

You may not qualify if:

• known hypersensitivity to any of the drugs
• recent treatment for H. pylori eradication

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (4)

Irmandade da Santa Casa de Misericordia se Sao Paulo

São Paulo, São Paulo, 01221-020, Brazil

Location

Centro de Hematologia de Sao Paulo

São Paulo, São Paulo, 01401-000, Brazil

Location

Federal University of Sao Paulo

São Paulo, São Paulo, 04021-001, Brazil

Location

Hospital Estadual Infantil Darcy Vargas

São Paulo, São Paulo, 05614-040, Brazil

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Elisabete Kawakami, Professor

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD MD

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: March 1, 2012
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

BR (4)