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NCT00511147 Clinical Trial

IGIV Study for Chronic ITP Patients Ages 3-70

Idiopathic Thrombocytopenic Purpura Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00511147
Other study ID # IG0601
Secondary ID
Status Completed
Phase Phase 3
First received August 1, 2007
Last updated February 17, 2016
Start date February 2008
Est. completion date March 2012

Study information
Verified date February 2016
Source Grifols Biologicals Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta
Canada St. Joseph's Healthcare Hamilton Ontario
Puerto Rico Fundacion de Investigacion de Diego San Juan
United States Emory University School of Medicine Winship Cancer Center Atlanta Georgia
United States Baptist Cancer Center Beaumont Texas
United States Halifax Health Medical Center Daytona Beach Florida
United States Cook Children's Medical Center Fort Worth Texas
United States Connecticut Children's Medical Center Hartford Connecticut
United States University of Iowa Children's Hospital Iowa City Iowa
United States University of Mississippi Jackson Mississippi
United States Capital Comprehensive Cancer Care Clinic Jefferson City Missouri
United States Kalamazoo Hematology & Oncology Kalamazoo Michigan
United States Scripps Cancer Center LaJolla California
United States Hematology Oncology Associates Lake Worth Florida
United States CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute Lansing Michigan
United States Kenmar Research Institute, LLC Los Angeles California
United States UMDNJ-RWJ Medical School New Brunswick New Jersey
United States Children's Hospital New Orleans Louisiana
United States Mt. Sinai Medical Center New York New York
United States Advocate Hope Children's Hospital Oak Lawn Illinois
United States Children's Hospital, University of Oklahoma Oklahoma City Oklahoma
United States Children's Hospital of Orange County Orange California
United States Phoenix Children's Hospital Phoenix Arizona
United States Western Pennsylvannia Hospital Pittsburgh Pennsylvania
United States MCV Hospital Richmond Virginia
United States Scottsdale Medical Specialists Scottsdale Arizona
United States Cancer Center of Central Connecticut Southington Connecticut
United States Lakeland Regional Cancer Center Tampa Florida
United States St. Joseph's Children's Hospital of Tampa Tampa Florida
United States Arizona Oncology Associates Tucson Arizona
United States Tyler Hematology Oncology PA Tyler Texas
United States Georgetown University Washington District of Columbia
United States VA Medical Center Washington District of Columbia
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)
Lead Sponsor Collaborator
Grifols Biologicals Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate that IGIV3I Grifols 10% is safe and effective in raising platelet counts in patients with ITP. 2 years Yes
See also
  Status Clinical Trial Phase
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Completed NCT00451594 - High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP Phase 3
Withdrawn NCT01276561 - Single Incision Versus Standard Laparoscopic Splenectomy N/A
Completed NCT01713855 - Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura N/A
Recruiting NCT03465020 - Investigation on a Dynamic Cohort of Italian Patients With Active ITP
Completed NCT00603642 - P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura Phase 3
Completed NCT01143038 - Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim Phase 2
Not yet recruiting NCT04128358 - Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind? N/A
Completed NCT00128882 - Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D Phase 2
Completed NCT01525836 - rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP Phase 3
Completed NCT00888901 - Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag Phase 4
Completed NCT00828750 - Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Phase 3
Completed NCT00625443 - Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003 Phase 2
Completed NCT00475423 - A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura. Phase 2
Completed NCT00454857 - Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) N/A
Completed NCT00102323 - AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy Phase 3
Completed NCT05492409 - Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients Phase 3
Terminated NCT01433978 - A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) Phase 3
Withdrawn NCT01443351 - Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Completed NCT01520909 - Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. Phase 3