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IGIV Study for Chronic ITP Patients Ages 3-70

This study is currently recruiting participants.
Verified August 2012 by Grifols Biologicals Inc.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT00511147
First received: August 1, 2007
Last updated: November 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: February 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2014 (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

  Eligibility

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511147

Contacts
Contact: Paul J Pinciaro, PhD 410-814-7617 paul.pinciaro@grifols.com

  Show 33 Study Locations
Sponsors and Collaborators
Grifols Biologicals Inc.
Investigators
Principal Investigator: Ali Khojasteh, MD Capitol Comprehensive Cancer Care Clinic
  More Information

No publications provided

Responsible Party: Grifols Biologicals Inc.
ClinicalTrials.gov Identifier: NCT00511147     History of Changes
Other Study ID Numbers: IG0601
Study First Received: August 1, 2007
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Grifols Biologicals Inc.:
IVIG
ITP

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
 Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013