Immune (Idiopathic) Thrombocytopenic PurpuraPhase 3ITPNCT00699140
Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura
A Phase 3 study testing IGIV3I Grifols in people with Immune (Idiopathic) Thrombocytopenic Purpura, run by Instituto Grifols, S.A. at 7 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Immune (Idiopathic) Thrombocytopenic Purpura
- What is being tested?
- IGIV3I Grifols
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Feb 2008to Dec 2013
- 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 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged between 18 and 82 at the time of written consent.
- Have confirmed diagnosis of chronic ITP and fulfil all the following criteria:
- irrelevant history except for the symptoms of bleeding,
- pattern of bleedings associated with platelet disorders,
- physical examination irrelevant for the ITP, except for the signs of bleeding,
- isolated thrombocytopenia in the blood count; apart from thrombocytopenia, the blood count is normal for the patient's age, or if abnormal, readily explained,
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- peripheral blood smear consistent with ITP: thrombocytopenia with platelets of normal size or slightly larger than normal, with absence of platelet clumps and giant platelets; normal red blood cell and white blood cell morphology,
- confirmed diagnosis of immune thrombocytopenic purpura or, when any abnormal finding is present, additional diagnostic evaluation excludes other causes of thrombocytopenia.
- Previous known diagnosis of ITP for at least 3 months.
- To show a platelet count platelet count ≤ 20x10^9/L at the moment of the first infusion with the study product.
- Have read the patient information and consent sheet, agreed to participate in the trial, and signed the consent sheet.
- Be expected to receive treatment over 5 days and follow-up for 3 months.
- For women of childbearing age, use adequate contraceptive method such as oral contraceptives, intrauterine device or tubal ligation during one-month period after the first infusion in the study.
Who cannot join
- Have immune thrombocytopenia secondary to other pathologies or drug mediated thrombocytopenia.
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- Present important active bleeding due to other reasons apart from the ITP.
- Exhibit an identifiable alternative cause of their thrombocytopenia, such as splenomegaly, family thrombocytopenia, bacteraemia, sepsis or active infection requiring or not therapy.
- Are presenting renal dysfunction.
- Have non-controlled arterial hypertension.
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- Have documented liver cirrhosis or any hepatic disorder with alanine aminotransferase (ALT) levels 2.5 times or more than the normal upper limit or bilirubin greater than 2 mg/dL.
- Are presenting a cardiac disease including a history of coronary artery disease, angina pectoris or congestive heart failure.
- Present known infection due to HIV or hepatitis C virus (HCV).
- Have been previously treated with IVIG or anti-D immunoglobulin being unresponsive.
- Have a history of serious adverse reactions or non-serious but frequent adverse reactions to intravenous immune globulin (IVIG) preparations or other products derived from blood.
- Have known allergies to any IGIV3I Grifols components, such as D-sorbitol.
- Are simultaneously participating in other clinical studies or have received an investigational drug in the 3 months prior to the start of the study.
- Have been involved in the present study and being treated with the formulation at 5% (IGIV3I Grifols 5%).
- Have conditions that might affect patient compliance.
- Are unable to provide a storage serum sample just before the first dose of IGIV3I Grifols.
- Are pregnant or nursing an infant child or unwilling to practice adequate birth control in 1-month period after the first infusion in the study.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Spain4 sites
Hospital General Vall d´Hebron
Barcelona
. Hospital de León
León
Hospital General Universitario La Paz
Madrid
Hospital Universitario La Fe
Valencia
Russia2 sites
Federal Research Clinical Centre of Pediatric Hematology, Oncology and Immunology Roszdrava
Moscow
Haematology Research Centre of Russian Academy of Medical Science
Moscow
About this study
Official title: Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I Grifols 10% (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura
The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura.
Read the detailed description
To determine if IGIV3I Grifols 10% is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:
- Increase of platelet count ≥ 50x10^9/L (primary objective).
- Time taken for the platelet count to reach ≥ 50x10^9/L.
- The length of time the platelet count remains ≥ 50x10^9/L.
- The maximum platelet level.
- Regression of bleeding episodes during the first 10 or 14 days.
To determine if IGIV3I Grifols 10% is safe with respect to:
Nature, severity and frequency of adverse reactions during and after infusions by percentage of subjects and percentage of infusions.
- Being tested
- IGIV3I Grifols
- Medical subject headings
- Purpura, Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGIV3I GrifolsBiological
Also called IGIV
Immune Globulin Intravenous (Human)
| Study group | Role | What they receive |
|---|---|---|
| 1 treatment group with IGIV3I Grifols | Experimental | Open label, non-randomized treatment group with IGIV3I Grifols
Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses. Receives: Biological: IGIV3I Grifols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Patients
The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.
Measured: At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).
Secondary outcomes (8)
Maximum Platelet Level Reached During the Follow-up Period
Platelet count was measured at various time points in the follow-up period after infusion.
Measured: During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)
The time taken for the platelet count to reach ≥ 50x10^9/L from first dose
Measured: At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)
Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1)
Measured: At any time during the study period (up to 3 months [90 days])
Regression of Hemorrhages.
Percentage of subjects with regression of hemorrhages of Types 1 to 3:
- Type 0: Patients without symptoms of bleeding at the first infusion continue without presenting spontaneous bleeding
- Type 1: Patients with bleeding symptoms at the first infusion had a reduction of the size of large ecchymoses, and no spontaneous appearance of new ecchymoses
- Type 2: Patients with bleeding symptoms at the first infusion had a decrease in the number of cutaneous petechiae, or the extent of the affected area of the body decreased
- Type 3: Patients had active mucosal bleedings at the first infusion, these episodes stopped without re-bleeding, and there was no occurrence of new spontaneous mucosal hemorrhages (e.g., gingival bleeding, epistaxis)
Measured: First 10 to14 days since the first infusion day (Day 1)
Frequency of Adverse Reactions During and After Infusions by Percentage of Patients
All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated.
Measured: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions
All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated.
Measured: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)
Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator's judgment) was listed.
Measured: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA
The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed
Measured: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for Immune (Idiopathic) Thrombocytopenic PurpuraStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María Teresa Álvarez, MD, Principal investigator, Hospital General Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699140
- Sponsor's protocol ID
- IG202
- Acronym
- ITP
- Status last verified
- Jan 2016
- First submitted
- 16 Jun 2008
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I Grifols 10% (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00699140
- Acronym / sponsor ID
- ITP / IG202
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 8 Feb 2016
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 determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura.
Detailed description
To determine if IGIV3I Grifols 10% is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:
- Increase of platelet count ≥ 50x10^9/L (primary objective).
- Time taken for the platelet count to reach ≥ 50x10^9/L.
- The length of time the platelet count remains ≥ 50x10^9/L.
- The maximum platelet level.
- Regression of bleeding episodes during the first 10 or 14 days.
To determine if IGIV3I Grifols 10% is safe with respect to:
Nature, severity and frequency of adverse reactions during and after infusions by percentage of subjects and percentage of infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 treatment group with IGIV3I Grifols | Experimental | Biological: IGIV3I GrifolsOpen label, non-randomized treatment group with IGIV3I Grifols Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be aged between 18 and 82 at the time of written consent.
- Have confirmed diagnosis of chronic ITP and fulfil all the following criteria:
- To show a platelet count platelet count ≤ 20x10^9/L at the moment of the first infusion with the study product.
- Have read the patient information and consent sheet, agreed to participate in the trial, and signed the consent sheet.
- Be expected to receive treatment over 5 days and follow-up for 3 months.
Key exclusion criteria (17 listed)
- Have immune thrombocytopenia secondary to other pathologies or drug mediated thrombocytopenia.
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- Present important active bleeding due to other reasons apart from the ITP.
- Exhibit an identifiable alternative cause of their thrombocytopenia, such as splenomegaly, family thrombocytopenia, bacteraemia, sepsis or active infection requiring or not therapy.
- Are presenting renal dysfunction.
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 |
|---|---|---|
| IGIV3I GrifolsAlso: IGIVImmune Globulin Intravenous (Human) | Biological | 1 treatment group with IGIV3I Grifols |
Primary outcome
Responder Patients
Time frame: At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).
The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.
8 secondary outcomes
Maximum Platelet Level Reached During the Follow-up Period
Time frame: During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)
Time frame: At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)
Time frame: At any time during the study period (up to 3 months [90 days])
Regression of Hemorrhages.
Time frame: First 10 to14 days since the first infusion day (Day 1)
Frequency of Adverse Reactions During and After Infusions by Percentage of Patients
Time frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions
Time frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)
Time frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA
Time frame: At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
María Teresa Álvarez, MD principal investigator
Hospital General Universitario La Paz
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IGIV3I Grifols in people with Immune (Idiopathic) Thrombocytopenic Purpura, run by Instituto Grifols, S.A. at 7 sites in 3 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 13 inclusion and 17 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Russia, United Kingdom. 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 8 Feb 2016). 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?
Responder Patients (time frame: At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).). 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 8 Feb 2016.