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IGIV Study for Chronic ITP Patients Ages 3-70

This study has been completed.
Information provided by (Responsible Party):
Grifols Biologicals Inc. Identifier:
First received: August 1, 2007
Last updated: February 17, 2016
Last verified: February 2016
Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by platelet destruction and thrombocytopenia (peripheral blood platelet count < 150 x 10(9)/L). IVIG therapy is useful in patients in whom the platelet count has to be raised either due to bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary goal of treatment is to maintain the platelet count at a hemostatic level. This study will test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic ITP.

Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Biological: IGIV3I Grifols 10%
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Prospective, Open-label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients With Idiopathic (Immune) Thrombocytopenic Purpura

Resource links provided by NLM:

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • To demonstrate that IGIV3I Grifols 10% is safe and effective in raising platelet counts in patients with ITP. [ Time Frame: 2 years ]

Enrollment: 58
Study Start Date: February 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGIV3I Grifols 10%
Intravenous immunoglobulin
Biological: IGIV3I Grifols 10%
IGIV3I Grifols 10% 1 g/kg/day is given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.
Other Name: Intravenous immunoglobulin


Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible subjects must be 3 to 70 years of age
  • Must have a diagnosis of chronic ITP
  • Must have a a platelet count ≤ 20 x 10(9)/L
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00511147

  Show 34 Study Locations
Sponsors and Collaborators
Grifols Biologicals Inc.
Principal Investigator: Ali Khojasteh, MD Capitol Comprehensive Cancer Care Clinic
  More Information

Responsible Party: Grifols Biologicals Inc. Identifier: NCT00511147     History of Changes
Other Study ID Numbers: IG0601
Study First Received: August 1, 2007
Last Updated: February 17, 2016

Keywords provided by Grifols Biologicals Inc.:

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on April 24, 2017