| June 16, 2008 |
| December 29, 2008 |
| February 2008 |
| May 2010 (final data collection date for primary outcome measure) |
| Increase of platelet count >/= 50,000/µl and regression of bleeding episodes. [ Time Frame: 10-14 days ] [ Designated as safety issue: No ] |
- Increase of platelet count >/= 50,000/µl [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Time taken for the platelet count to reach >/= 50,000/µl [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- The length of time the platelet count remains >/= 50,000/µl [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- The maximum platelet level [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Regression of bleeding episodes during the first 10 or 14 days [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
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| Complete list of historical versions of study NCT00699140 on ClinicalTrials.gov Archive Site |
- Changes in vital signs and clinically relevant changes in laboratory parameters after the infusions, including renal function (creatinine levels) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Viral safety through the investigation of patients virology status (HAV, HBV, HCV and HIV) and assessment of alteration in their liver function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Nature, severity and frequency of adverse reactions during and after infusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Frequency of responders (platelet count >/= 50,000/µl [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Time to reach platelet count >/= 50,000/µl [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Length of time platelet count remains ./= 50,000/µl. [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]
- Regression of hemorrhages. [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]
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- Changes in vital signs and clinically relevant changes in laboratory parameters after the infusions, including renal function (creatinine levels) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Viral safety through the investigation of patients virology status (HAV, HBV, HCV and HIV) and assessment of alteration in their liver function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Nature, severity and frequency of adverse reactions during and after infusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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| |
| Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura |
| Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I 10% Grifols (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura |
The purpose of this study is to determine whether IGIV3I 10% Grifols is effective in the treatment of immune thrombocytopenic purpura. |
To determine if IGIV3I 10% Grifols is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:
- Increase of platelet count > 50,000/µl (primary objective).
- Time taken for the platelet count to reach > 50,000/µl.
- The length of time the platelet count remains > 50,000/µl.
- The maximum platelet level.
- Regression of bleeding episodes during the first 10 or 14 days.
To determine if IGIV3I Grifols is safe with respect to:
- Nature, severity and frequency of adverse reactions during and after infusions.
- Changes in vital signs and clinically relevant changes in laboratory parameters after the infusions, including renal function (creatinine levels).
- Viral safety through the investigation of patients virology status (HAV, HBV, HCV and HIV) and assessment of alteration in their liver function.
|
| Phase III |
| Interventional |
| Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Idiopathic Thrombocytopenic Purpura |
| Biological: IGIV3I Grifols |
| Experimental: Open label, non-randomized |
| |
| |
| Recruiting |
| 20 |
| May 2010 |
| May 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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,
- 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 < 30,000/µl 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 (IUD) or tubal ligation during one-month period after the first infusion in the study.
Exclusion Criteria:
- 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.
- Have documented liver cirrhosis or any hepatic disorder with 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 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 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.
|
| Both |
| 18 Years to 82 Years |
| No |
|
| Russian Federation, Spain, United Kingdom |
| |
| NCT00699140 |
| Marta Carretero, Pharm D, Instituto Grifols, S.A. |
| IG-202 |
| Grifols Biologicals Inc. |
|
| Study Chair: |
Antonio Julia, MD |
Hospital General Vall Hebron |
|
|
| Grifols Biologicals Inc. |
| December 2008 |