Clinical trial NCT00511147: IGIV Study for Chronic ITP Patients Ages 3-70
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: IVIG
ITP
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
Collaborators: name: Instituto Grifols, S.A.
First posted: 2007-08-03
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of chronic ITP
* 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

Key Exclusion Criteria:

* History or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia
* 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

Primary outcomes:
measure: Response Rate
timeFrame: 8 days
Secondary outcomes:
measure: Time to Platelet Count Recovery
timeFrame: 30 days
measure: Duration of Response
timeFrame: 30 days
measure: Regression of Hemorrhage/Bleedings
timeFrame: 15 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Medical Specialists
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute, LLC
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Washington, D.C.
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington, D.C.
country: United States
facility: VA Medical Center
state: District of Columbia
city: Daytona Beach
country: United States
facility: Halifax Health Medical Center
state: Florida
city: Lake Worth
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Tampa
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital of Tampa
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine Winship Cancer Center
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Hope Children's Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
city: New Orleans
country: United States
facility: Children's Hospital
state: Louisiana
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology & Oncology
state: Michigan
city: Lansing
country: United States
facility: CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Jefferson City
country: United States
facility: Capital Comprehensive Cancer Care Clinic
state: Missouri
city: New Brunswick
country: United States
facility: UMDNJ-RWJ Medical School
state: New Jersey
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Children's Hospital, University of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: Western Pennsylvannia Hospital
state: Pennsylvania
city: Beaumont
country: United States
facility: Baptist Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology Oncology PA
state: Texas
city: Richmond
country: United States
facility: MCV Hospital
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Karnataka
country: India
facility: Narayana Hrudayalaya Hospitals
state: Bangalore
city: Ahmedabad
country: India
facility: Shalby Hospitals
city: Bangalore
country: India
facility: St. John's Medical College Hospital
city: Haryana
country: India
facility: Artemis Health Institute
city: Kolkata
country: India
facility: Netaji Subhash Chandra Bose Cancer Research Institute
city: Ludhiana
country: India
facility: Christian Medical College
city: Maharashtra
country: India
facility: Kodlikeri Hospital
city: Pune
country: India
facility: Grant Medical Foundation, Ruby Hall Clinic
city: Pune
country: India
facility: Sahyadri Specialty Hospital
city: Surat
country: India
facility: Apple Hospital
city: Vellore
country: India
facility: Christian Medical College
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Capitol Comprehensive Cancer Care Clinic
name: Ali Khojasteh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.