Idiopathic Thrombocytopenic Purpura (ITP)Phase 3NCT00362349
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
A Phase 3 study testing IgNextGen 10% in people with Idiopathic Thrombocytopenic Purpura (ITP), run by CSL Limited at 8 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura (ITP)
- What is being tested?
- IgNextGen 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 8 sitesAustralia
- Study dates
- Jun 2007to Oct 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of ITP
- platelet count of <50 X 10^9
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Redcliffe Hospital
Brisbane, Queensland
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Monash Medical Centre
Melbourne, Victoria, 3168
Royal Perth Hospital
Perth, Western Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
St George Hospital
Sydney, New South Wales, 2217
About this study
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)
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.
- Being tested
- IgNextGen 10%
- Keywords
- ITP, IVIg, Platelet count, Bleeding
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IVIg Receives: Drug: IgNextGen 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: 90 days
Secondary outcomes (1)
Safety
Measured: 97 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic Purpura (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beng N/A Chong, Professor, Principal investigator, The St George Hospital (NSW, Australia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362349
- Sponsor's protocol ID
- CSLCT-ITP-05-21
- Status last verified
- Feb 2009
- First submitted
- 9 Aug 2006
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00362349
- Acronym / sponsor ID
- CSLCT-ITP-05-21
- Keywords
- ITP, IVIg, Platelet count, Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- CSL LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IgNextGen 10%IVIg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of ITP
- platelet count of <50 X 10^9
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | 1 |
Primary outcome
Efficacy
Time frame: 90 days
1 secondary outcome
Safety
Time frame: 97 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beng N/A Chong, Professor principal investigator
The St George Hospital (NSW, Australia)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IgNextGen 10% in people with Idiopathic Thrombocytopenic Purpura (ITP), run by CSL Limited at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016; AzTrials last refreshed its copy on 26 Oct 2026.