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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362349

Enrollment

Registered

2006-08-10

Start date

2007-06-30

Completion date

2008-10-31

Last updated

2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenic Purpura (ITP)

Keywords

ITP, IVIg, Platelet count, Bleeding

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.

Interventions

DRUGIgNextGen 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Efficacy	90 days

Secondary

Measure	Time frame
Safety	97 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026