Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2008-05-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IGIV3I Grifols 10% (All Subjects)
All subjects with Chronic ITP
IGIV3I Grifols 10%
IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.
Interventions
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IGIV3I Grifols 10%
IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Platelet count ≤ 20 x 10\^9/L
* When administered corticosteroids at any time within 3 weeks before screening visit, the subject must have completed at least 3 weeks (21 days) of therapy at a stable and constant dose and schedule prior to screening visit
* When administered azathioprine (immunosuppressant) at any time within 3 months before screening visit, the subject must have received a stable dose and schedule for at least 3 months prior to screening visit
* When administered vinca alkaloids (eg., vincristine) at any time within 2 weeks before screening visit, the subject must have received a stable dose and schedule for at least 2 weeks prior to screening visit
* When administered attenuated androgens (eg, danazol) at any time within 8 weeks before screening visit, the subject must have received a stable dose and schedule for at least 8 weeks prior to screening visit.
* Females of childbearing potential must test negative for pregnancy
Exclusion Criteria
* Diagnosis of secondary immune thrombocytopenia
* History of severe (eg, anaphylactic) reactions to blood or any blood- derived product
* History of intolerance to any component of the IP, such as sorbitol
* Suffering serious and/or life-threatening hemorrhage/bleeding defined as:
* Any intracranial or central nervous system bleeding
* Any hemorrhagic event in which the subject is at risk of death at the time of the event
* Females who are pregnant or nursing an infant child
* Known to have immunoglobulin A (IgA) deficiency
* Known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or has done so within 12 months of the screening visit
* Documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past
* Unstable or uncontrolled disease, or condition, related to, or impacting, cardiac function: unstable angina, congestive heart failure, uncontrolled arterial hypertension
* Is anemic (hemoglobin \< 9 g/dL)
* Renal impairment (ie, serum creatinine \> 1.5 x upper limit of normal \[ULN\])
* Aspartate aminotransferase or alanine aminotransferase levels \> 2.5 x ULN
* Known to have a positive test for either HCV or HIV (HIV 1/2)
* Splenectomy within the prior 8 weeks to the screening visit
* currently receiving any treatment for ITP except corticosteroids, azathioprine, vinca alkaloids or danazol
* Received an immune serum globulin (ISG) product within the prior 3 weeks (21 days) to the screening visit
* Received any alkylating agent (eg, cyclophosphamide) within 5 weeks prior to the screening visit
* Received rituximab within the prior 3 months to the screening visit
* Was currently receiving, or received, any therapeutic drug or device that was not approved by a Regulatory Authority (US or Canadian) for any indication within the prior 12 weeks to the screening visit
3 Years
70 Years
ALL
No
Sponsors
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Instituto Grifols, S.A.
INDUSTRY
Grifols Biologicals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Ali Khojasteh, MD
Role: PRINCIPAL_INVESTIGATOR
Capitol Comprehensive Cancer Care Clinic
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Scottsdale Medical Specialists
Scottsdale, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
Scripps Cancer Center
La Jolla, California, United States
Kenmar Research Institute, LLC
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
VA Medical Center
Washington D.C., District of Columbia, United States
Halifax Health Medical Center
Daytona Beach, Florida, United States
Hematology Oncology Associates
Lake Worth, Florida, United States
Lakeland Regional Cancer Center
Tampa, Florida, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University School of Medicine Winship Cancer Center
Atlanta, Georgia, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Children's Hospital
New Orleans, Louisiana, United States
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, United States
CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
Lansing, Michigan, United States
University of Mississippi
Jackson, Mississippi, United States
Capital Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
UMDNJ-RWJ Medical School
New Brunswick, New Jersey, United States
Mt. Sinai Medical Center
New York, New York, United States
Children's Hospital, University of Oklahoma
Oklahoma City, Oklahoma, United States
Western Pennsylvannia Hospital
Pittsburgh, Pennsylvania, United States
Baptist Cancer Center
Beaumont, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Tyler Hematology Oncology PA
Tyler, Texas, United States
MCV Hospital
Richmond, Virginia, United States
University of Alberta
Edmonton, Alberta, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Narayana Hrudayalaya Hospitals
Karnataka, Bangalore, India
Shalby Hospitals
Ahmedabad, , India
St. John's Medical College Hospital
Bangalore, , India
Artemis Health Institute
Haryāna, , India
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, , India
Christian Medical College
Ludhiana, , India
Kodlikeri Hospital
Maharashtra, , India
Grant Medical Foundation, Ruby Hall Clinic
Pune, , India
Sahyadri Specialty Hospital
Pune, , India
Apple Hospital
Surat, , India
Christian Medical College
Vellore, , India
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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References
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Apte S, Navarro-Puerto J, Damodar S, Ramanan V, John J, Kato G, Ross C, Shah C, Torres M, Fu C', Rucker K, Pinciaro P, Barrera G, Aragones ME, Ayguasanosa J. Safety and efficacy of intravenous immunoglobulin (Flebogamma(R) 10% DIF) in patients with immune thrombocytopenic purpura. Immunotherapy. 2019 Feb;11(2):81-89. doi: 10.2217/imt-2018-0165. Epub 2018 Nov 30.
Other Identifiers
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IG0601
Identifier Type: -
Identifier Source: org_study_id
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