Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00362349




Registration number
NCT00362349
Ethics application status
Date submitted
9/08/2006
Date registered
10/08/2006
Date last updated
18/07/2016

Titles & IDs
Public title
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
Scientific 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)
Secondary ID [1] 0 0
CSLCT-ITP-05-21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Thrombocytopenic Purpura (ITP) 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IgNextGen 10%

Experimental: 1 - IVIg


Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Safety
Timepoint [1] 0 0
97 days

Eligibility
Key inclusion criteria
- clinical diagnosis of ITP

- platelet count of <50 X 10^9
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [3] 0 0
St George Hospital - Sydney
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Redcliffe Hospital - Brisbane
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
2217 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Melbourne
Recruitment postcode(s) [8] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Limited
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00362349
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Beng N/A Chong, Professor
Address 0 0
The St George Hospital (NSW, Australia)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00362349