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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
Open (Enrolling)
Both
Idiopathic Thrombocytopenic Purpura

Thank you

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 CountyOrange, California  92668
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
St. Joseph's Children's Hospital of TampaTampa, Florida  33677-4227
Hematology Oncology AssociatesAtlantis, Florida  33462
Connecticut Children's Medical CenterHartford, Connecticut  06106
Georgetown UniversityWashington, District of Columbia  20007-2197
Scripps Cancer CenterLa Jolla, California  92037
Arizona Oncology AssociatesTucson, Arizona  85712-2254
Lakeland Regional Cancer CenterLakeland, Florida  33805
Tyler Hematology Oncology PATyler, Texas  75701
Mt. Sinai Medical CenterNew York, New York  10029
Kenmar Research Institute, LLCLos Angeles, California  90057
Kalamazoo Hematology & OncologyKalamazoo, Michigan  49048
Children's HospitalNew Orleans, Louisiana  70118
Cook Children's Medical CenterFort Worth, Texas  76104
Cancer Center of Central ConnecticutSouthington, Connecticut  
University of MississippiJackson, Mississippi  39216
Scottsdale Medical SpecialistsScottsdale, Arizona  85258
VA Medical CenterWashington, District of Columbia  20422
Halifax Health Medical CenterDaytona Beach, Florida  32114
Cleveland Clinic FloridaWeston, Florida  33331
Emory University School of Medicine Winship Cancer CenterAtlanta, Georgia  30322
University of Iowa Children's HospitalIowa City, Iowa  52242
CTO Breslin Cancer Center/MSU/Great Lakes Cancer InstituteLansing, Michigan  48910
Capital Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
UMDNJ-RWJ Medical SchoolNew Brunswick, New Jersey  08901
Children's Hospital, University of OklahomaOklahoma City, Oklahoma  73104
Western Pennsylvannia HospitalPittsburgh, Pennsylvania  15224
Baptist Cancer CenterBeaumont, Texas  77705
MCV HospitalRichmond, Virginia  23298