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
Phase 3
3 Years
70 Years
3 Years
70 Years
Open (Enrolling)
Both
Idiopathic Thrombocytopenic Purpura
Both
Idiopathic Thrombocytopenic Purpura
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To demonstrate that IGIV3I Grifols 10% is safe and effective in raising platelet counts in patients with ITP.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Ali Khojasteh, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Capitol Comprehensive Cancer Care Clinic
Authority:
United States: Food and Drug Administration
Study ID:
IG0601
NCT ID:
NCT00511147
Start Date:
February 2008
Completion Date:
June 2015
Related Keywords:
- Idiopathic Thrombocytopenic Purpura
- IVIG
- ITP
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Name | Location |
|---|---|
| Children's Hospital of Orange County | Orange, California 92668 |
| Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
| St. Joseph's Children's Hospital of Tampa | Tampa, Florida 33677-4227 |
| Hematology Oncology Associates | Atlantis, Florida 33462 |
| Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
| Georgetown University | Washington, District of Columbia 20007-2197 |
| Scripps Cancer Center | La Jolla, California 92037 |
| Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Tyler Hematology Oncology PA | Tyler, Texas 75701 |
| Mt. Sinai Medical Center | New York, New York 10029 |
| Kenmar Research Institute, LLC | Los Angeles, California 90057 |
| Kalamazoo Hematology & Oncology | Kalamazoo, Michigan 49048 |
| Children's Hospital | New Orleans, Louisiana 70118 |
| Cook Children's Medical Center | Fort Worth, Texas 76104 |
| Cancer Center of Central Connecticut | Southington, Connecticut |
| University of Mississippi | Jackson, Mississippi 39216 |
| Scottsdale Medical Specialists | Scottsdale, Arizona 85258 |
| VA Medical Center | Washington, District of Columbia 20422 |
| Halifax Health Medical Center | Daytona Beach, Florida 32114 |
| Cleveland Clinic Florida | Weston, Florida 33331 |
| Emory University School of Medicine Winship Cancer Center | Atlanta, Georgia 30322 |
| University of Iowa Children's Hospital | Iowa City, Iowa 52242 |
| CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute | Lansing, Michigan 48910 |
| Capital Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
| UMDNJ-RWJ Medical School | New Brunswick, New Jersey 08901 |
| Children's Hospital, University of Oklahoma | Oklahoma City, Oklahoma 73104 |
| Western Pennsylvannia Hospital | Pittsburgh, Pennsylvania 15224 |
| Baptist Cancer Center | Beaumont, Texas 77705 |
| MCV Hospital | Richmond, Virginia 23298 |
