NCT00362349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

July 18, 2016

Status Verified

February 1, 2009

Enrollment Period

1.3 years

First QC Date

August 9, 2006

Last Update Submit

July 14, 2016

Conditions

Idiopathic Thrombocytopenic Purpura (ITP)

Keywords

ITPIVIgPlatelet countBleeding

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    90 days

Secondary Outcomes (1)

  • Safety

    97 days

Study Arms (1)

1

EXPERIMENTAL

IVIg

Drug: IgNextGen 10%

Interventions

IgNextGen 10%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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

St George Hospital

Sydney, New South Wales, 2217, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Redcliffe Hospital

Brisbane, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicHemorrhage

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Beng N/A Chong, Professor

    The St George Hospital (NSW, Australia)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 10, 2006

Study Start

June 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

July 18, 2016

Record last verified: 2009-02

Locations

AU(8)