|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 August 2016 |
|
Main ID: |
NCT00362349 |
|
Date of registration:
|
09/08/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
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) |
|
Date of first enrolment:
|
June 2007 |
|
Target sample size:
|
19 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00362349 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Australia
| | | | | | | |
|
Contacts
|
|
Name:
|
Beng N/A Chong, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The St George Hospital (NSW, Australia) |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Thrombocytopenic Purpura (ITP)
|
|
Intervention(s)
|
|
Drug: IgNextGen 10%
|
|
Primary Outcome(s)
|
|
Efficacy
[Time Frame: 90 days]
|
|
Secondary Outcome(s)
|
|
Safety
[Time Frame: 97 days]
|
|
Secondary ID(s)
|
|
CSLCT-ITP-05-21
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|