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Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients

NCT00362349 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-07-18

No results posted yet for this study

Summary

Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by isolated low platelet counts. The aim of treating patients with ITP is to increase the platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy and safety of Ig NextGen 10% in adult patients with ITP.

Conditions

  • Idiopathic Thrombocytopenic Purpura (ITP)

Interventions

DRUG

IgNextGen 10%

Ig NextGen 10% is a liquid formulation and is to be administered intravenously. At the discretion of the Investigator, patients could be administered Ig NextGen 10% in accordance with either of two dosage regimens: Regimen One: 1 g/kg body weight of Ig NextGen 10% administered daily for two days. Regimen Two: 0.4 g/kg body weight of Ig NextGen 10% administered daily for five days

Sponsors & Collaborators

Principal Investigators

  • Beng N/A Chong, Professor · The St George Hospital (NSW, Australia)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362349 on ClinicalTrials.gov