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Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients | Clinical Trials | Clareo Health

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

A Single-arm, Open Label, Multi-centre Study Evaluating the Efficacy and Safety of Ig NexGen 10% in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

NCT00362349•CSL Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•clinical diagnosis of ITP
•platelet count of \<50 X 10\^9

Exclusion Criteria

•planned splenectomy
•previous non-responders to IVIg treatment
•known or suspected hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy
•patients who have received treatment with:
•1. IVIg or anti-D immunoglobulin
•2. immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
•3. patients who have received IV administration of steroids OR have had a change of oral corticosteroid treatment OR danazol within 15 days prior to first day of study drug administration.

Locations (8)

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

St George Hospital

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Redcliffe Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Medical Centre

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Key Dates

Start Date

June 1, 2007

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

July 18, 2016

Enrollment

ACTUAL participants

Conditions

Idiopathic Thrombocytopenic Purpura (ITP)

Interventions

IgNextGen 10%

DRUG

A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone

NCT00161564

Idiopathic Thrombocytopenic Purpura (ITP)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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