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Sponsored by: |
Grifols Biologicals Inc. |
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Information provided by: | Grifols Biologicals Inc. |
ClinicalTrials.gov Identifier: | NCT00699140 |
The purpose of this study is to determine whether IGIV3I 10% Grifols is effective in the treatment of immune thrombocytopenic purpura.
Condition | Intervention | Phase |
---|---|---|
Idiopathic Thrombocytopenic Purpura |
Biological: IGIV3I Grifols |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Trial to Evaluate the Efficacy and the Safety of IGIV3I 10% Grifols (Human Intravenous Immunoglobulin) in Patients Diagnosed With Immune Thrombocytopenic Purpura |
Estimated Enrollment: | 20 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Open label, non-randomized
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Biological: IGIV3I Grifols
Immune Globulin Intravenous (Human)
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To determine if IGIV3I 10% Grifols is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:
To determine if IGIV3I Grifols is safe with respect to:
Ages Eligible for Study: | 18 Years to 82 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have confirmed diagnosis of chronic ITP and fulfil all the following criteria:
Exclusion Criteria:
Russian Federation | |
Botkin City Clinical Hospital | Completed |
Moscow, Russian Federation | |
Haematology Research Centre of Russian Academy of Medical Science | Completed |
Moscow, Russian Federation | |
Spain | |
Hospital General Universitario La Paz | Completed |
Madrid, Spain | |
Hospital General Vall d´Hebron | Completed |
Barcelona, Spain | |
Hospital de Bellvitge | Completed |
Barcelona, Spain | |
Hospital de la Santa Creu i Sant Pau | Completed |
Barcelona, Spain | |
Hospital Universitario La Fe | Completed |
Valencia, Spain | |
. Hospital de León | Completed |
Leon, Spain | |
Hospital Universitario de Salamanca | Completed |
Salamanca, Spain | |
United Kingdom | |
Hillingdon Hospital | Recruiting |
Middlesex, United Kingdom, UB8 3NN | |
Contact: Richard Kaczmarkski, MD r.kaczmarski@imperial.ac.uk | |
Principal Investigator: Richard Kaczmarski, MD | |
University College of London | Recruiting |
London, United Kingdom, NW1 2PG | |
Contact: S Machin, MD 0845 155 5000 ext 9884 | |
Principal Investigator: M Machin, MD | |
Derriford Hospital | Recruiting |
Plymouth, United Kingdom, PL6 8DH | |
Contact: T Nokes, MD Tim.Nokes@phnt.swest.nhs.uk | |
Principal Investigator: T Nokes, MD |
Study Chair: | Antonio Julia, MD | Hospital General Vall Hebron |
Responsible Party: | Instituto Grifols, S.A. ( Marta Carretero, Pharm D ) |
Study ID Numbers: | IG-202 |
Study First Received: | June 16, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00699140 History of Changes |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Purpura Autoimmune Diseases Immunologic Factors Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemostatic Disorders Purpura, Thrombocytopenic Signs and Symptoms |
Thrombocytopathy Antibodies Thrombocytopenia Hemorrhagic Disorders Immunoglobulins, Intravenous Thrombocytopenic Purpura, Autoimmune Purpura, Thrombocytopenic, Idiopathic Rho(D) Immune Globulin Immunoglobulins |
Purpura Skin Manifestations Autoimmune Diseases Immunologic Factors Immune System Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders |
Physiological Effects of Drugs Pharmacologic Actions Purpura, Thrombocytopenic Signs and Symptoms Thrombocytopenia Hemorrhagic Disorders Immunoglobulins, Intravenous Purpura, Thrombocytopenic, Idiopathic |