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

NCT ID: NCT00362349

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-10-31

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

IVIg

Group Type: EXPERIMENTAL

IgNextGen 10%

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beng N/A Chong, Professor

Role: PRINCIPAL_INVESTIGATOR

The St George Hospital (NSW, Australia)

Locations

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

Countries

Australia

Other Identifiers

CSLCT-ITP-05-21

Identifier Type: -

Identifier Source: org_study_id