Immune Thrombocytopenic PurpuraPhase 3NCT00168038
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
A Phase 3 study testing Immunoglobulin Intravenous (Human) in people with Immune Thrombocytopenic Purpura, run by CSL Behring at 17 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10^9/L. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- Immunoglobulin Intravenous (Human)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Dec 2004to Feb 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of chronic ITP defined by: Failure to find other causes of thrombocytopenia; Platelet count ≤ 150 x 10^9/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months
- Platelet counts ≤ 20 x 10^9/L
Who cannot join
- Planned splenectomy throughout the study period
- Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening
- Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening
- Treatment with intravenous steroids within 10 days prior to screening
- Change of oral steroid treatment within 15 days prior to screening
- Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy
Show all 10Show fewer
- Abnormal results in the following laboratory parameters: Hemoglobin < 10 g/dL; Total bilirubin > 1.5 x upper normal limit; ALAT > 2.5 x upper normal limit; ASAT > 2.5 x upper normal limit; Creatinine > 1.5 x upper normal limit; Urea > 1.5 x upper normal limit
- Positive direct Coombs test
- Patients with one of the following concomitant diseases Clinical active SLE Known or suspected HIV infection Acute hepatitis Clinically active chronic hepatitis Lymphoproliferative disease Heart failure Grade III or IV according to the New York Heart Association classification
- Any other concomitant disease that has influence on the clotting system (i.e. hemophilia)
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Poland6 sites
Study Site
Bialystok
Study Site
Gdansk
Study Site
Lodz
Study Site
Poznan
Study Site
Warsaw
Study Site
Wroclaw
Russia4 sites
Study Site
Moscow
Study Site (19)
Saint Petersburg
Study Site (20)
Saint Petersburg
Study Site (21)
Saint Petersburg
Ukraine4 sites
Study Site
Dnipropetrovsk
Study Site (02)
Kyiv
Study Site (03)
Kyiv
Study Site
Lviv
About this study
Official title: An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10^9/L.
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- Immunoglobulin Intravenous (Human)
- Keywords
- Chronic Immune Thrombocytopenic Purpura, Chronic Idiopathic Thrombocytopenic Purpura, Werlhofs Disease, Autoimmune Thrombocytopenia, Immunglobulin Intravenous, Chronic ITP, Platelet count, Thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin Intravenous (Human)Biological
Also called Privigen, IgPro10
A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.
| Study group | Role | What they receive |
|---|---|---|
| IgPro10 | Experimental | Not described Receives: Biological: Immunoglobulin Intravenous (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Response
The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.
Measured: 7 days
Secondary outcomes (8)
Regression of Hemorrhage (Skin)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Measured: up to 29 days
Regression of Hemorrhage (Oral Cavity)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Measured: 29 days
Regression of Hemorrhage (Genitourinary Tract)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Measured: 29 days
Regression of Hemorrhage (Nose)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Measured: 29 days
Regression of Hemorrhage (Internal)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Measured: 29 days
Time to Platelet Response
Median time to reach a platelet count ≥ 50 x 10^9/L.
Measured: 29 days
Duration of Platelet Response
The number of days the platelet count remained ≥ 50 x 10^9/L.
Measured: up to 29 days
Maximum Platelet Level
Maximum absolute platelet count achieved over the duration of the study.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Othmar Zenker, MD, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168038
- Sponsor's protocol ID
- ZLB03_003CR
- Other IDs
- 2004-000537-11, 2004
- Status last verified
- Oct 2011
- First submitted
- 12 Sep 2005
- Last updated
- 23 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Robak T, Salama A, Kovaleva L, Vyhovska Y, Davies SV, Mazzucconi MG, Zenker O, Kiessling P; International Privigen in ITP Study Group. Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009 Aug;14(4):227-36. doi: 10.1179/102453309X439773.
PubMed 19635187
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT00168038
- Acronym / sponsor ID
- ZLB03_003CR
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- Chronic Immune Thrombocytopenic Purpura, Chronic Idiopathic Thrombocytopenic Purpura, Werlhofs Disease, Autoimmune Thrombocytopenia, Immunglobulin Intravenous, Chronic ITP, Platelet count, Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 23 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10^9/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgPro10 | Experimental | Biological: Immunoglobulin Intravenous (Human) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic ITP defined by: Failure to find other causes of thrombocytopenia; Platelet count ≤ 150 x 10^9/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months
- Platelet counts ≤ 20 x 10^9/L
Key exclusion criteria (10 listed)
- Planned splenectomy throughout the study period
- Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening
- Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening
- Treatment with intravenous steroids within 10 days prior to screening
- Change of oral steroid treatment within 15 days prior to screening
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 |
|---|---|---|
| Immunoglobulin Intravenous (Human)Also: Privigen, IgPro10A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw. | Biological | IgPro10 |
Primary outcome
Platelet Response
Time frame: 7 days
The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.
8 secondary outcomes
Regression of Hemorrhage (Skin)
Time frame: up to 29 days
Regression of Hemorrhage (Oral Cavity)
Time frame: 29 days
Regression of Hemorrhage (Genitourinary Tract)
Time frame: 29 days
Regression of Hemorrhage (Nose)
Time frame: 29 days
Regression of Hemorrhage (Internal)
Time frame: 29 days
Time to Platelet Response
Time frame: 29 days
Duration of Platelet Response
Time frame: up to 29 days
Maximum Platelet Level
Time frame: 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19635187Robak T, Salama A, Kovaleva L, Vyhovska Y, Davies SV, Mazzucconi MG, Zenker O, Kiessling P; International Privigen in ITP Study Group. Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009 Aug;14(4):227-36. doi: 10.1179/102453309X439773.
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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.
Othmar Zenker, MD study director
CSL Behring
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunoglobulin Intravenous (Human) in people with Immune Thrombocytopenic Purpura, run by CSL Behring at 17 sites in 6 countries.
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 10 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 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Poland, Russia, Ukraine, Germany, Italy and 1 more country. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Platelet Response (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168038, which also lists 1 linked publication.
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 23 Nov 2011.