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

Sponsor

CSL Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT00362349

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Thrombocytopenic Purpura (ITP)	Drug: IgNextGen 10%	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 IVIg	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

Arm

Intervention/Treatment

Experimental: 1

IVIg

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

Outcome Measures

Primary Outcome Measures

Efficacy [90 days]

Secondary Outcome Measures

Safety [97 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

IVIg or anti-D immunoglobulin
immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Canberra Hospital	Canberra	Australian Capital Territory	Australia	2605
2	Royal Prince Alfred Hospital	Sydney	New South Wales	Australia	2050
3	St George Hospital	Sydney	New South Wales	Australia	2217
4	Princess Alexandra Hospital	Brisbane	Queensland	Australia	4102
5	Redcliffe Hospital	Brisbane	Queensland	Australia
6	Royal Adelaide Hospital	Adelaide	South Australia	Australia
7	Monash Medical Centre	Melbourne	Victoria	Australia	3168
8	Royal Perth Hospital	Perth	Western Australia	Australia