Status:
COMPLETED
Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura
Lead Sponsor:
Instituto Grifols, S.A.
Conditions:
Immune (Idiopathic) Thrombocytopenic Purpura
Eligibility:
All Genders
18-82 years
Phase:
PHASE3
Brief Summary
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: 1. Increase of platelet count ≥ 50x10\^9/L (primar...
Eligibility Criteria
Inclusion
- 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 ≤ 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.
Exclusion
- 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 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00699140
Start Date
February 1 2008
End Date
December 1 2013
Last Update
February 8 2016
Active Locations (7)
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1
Federal Research Clinical Centre of Pediatric Hematology, Oncology and Immunology Roszdrava
Moscow, Russia
2
Haematology Research Centre of Russian Academy of Medical Science
Moscow, Russia
3
Hospital General Vall d´Hebron
Barcelona, Spain
4
. Hospital de León
León, Spain