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| Sponsored by: |
Grifols Biologicals Inc. |
|---|---|
| Information provided by: | Grifols Biologicals Inc. |
| ClinicalTrials.gov Identifier: | NCT00699140 |
Purpose
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
|
Biological: IGIV3I Grifols
Immune Globulin Intravenous (Human)
|
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:
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 |