IGIV Study for Chronic ITP Patients Ages 3-70

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Thrombocytopenic Purpura
• Intervention / Treatment: Biological: IGIV3I Grifols 10%

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2H7
      • University of Alberta
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • St. Joseph's Healthcare
• India
  • Ahmedabad, India, 380015
    • Shalby Hospitals
  • Bangalore, India, 560034
    • St. John's Medical College Hospital
  • Haryana, India, 122001
    • Artemis Health Institute
  • Kolkata, India, 700 016
    • Netaji Subhash Chandra Bose Cancer Research Institute
  • Ludhiana, India, 141008
    • Christian Medical College
  • Maharashtra, India, 431001
    • Kodlikeri Hospital
  • Pune, India, 411001
    • Grant Medical Foundation, Ruby Hall Clinic
  • Pune, India, 411004
    • Sahyadri Specialty Hospital
  • Surat, India, 395002
    • Apple Hospital
  • Vellore, India, 632004
    • Christian Medical College
  • Bangalore
    • Karnataka, Bangalore, India, 560099
      • Narayana Hrudayalaya Hospitals
• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Fundacion De Investigacion de Diego
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85061
      • Phoenix Children's Hospital
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Medical Specialists
    • Tucson, Arizona, United States, 85745
      • Arizona Oncology Associates
  • California
    • La Jolla, California, United States, 92037
      • Scripps Cancer Center
    • Los Angeles, California, United States, 90057
      • Kenmar Research Institute, LLC
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
    • Southington, Connecticut, United States, 06489
      • Cancer Center of Central Connecticut
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20007
      • Georgetown University
    • Washington, D.C., District of Columbia, United States, 20422
      • VA Medical Center
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Halifax Health Medical Center
    • Lake Worth, Florida, United States, 33461
      • Hematology Oncology Associates
    • Tampa, Florida, United States, 33607-6307
      • Lakeland Regional Cancer Center
    • Tampa, Florida, United States, 33607-6307
      • St. Joseph's Children's Hospital of Tampa
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine Winship Cancer Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Hope Children's Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Children's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Kalamazoo Hematology & Oncology
    • Lansing, Michigan, United States, 48910
      • CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Capital Comprehensive Cancer Care Clinic
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • UMDNJ-RWJ Medical School
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Children's Hospital, University of Oklahoma
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvannia Hospital
  • Texas
    • Beaumont, Texas, United States, 77705
      • Baptist Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
    • Tyler, Texas, United States, 75701
      • Tyler Hematology Oncology PA
  • Virginia
    • Richmond, Virginia, United States, 23298
      • MCV Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IGIV3I Grifols 10% (All Subjects); All subjects with Chronic ITP	Biological: 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 Names: Intravenous immunoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate	Defined by the percentage of treated patients in whom platelet counts increase from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L by Day 8 ± 1 [where the day of the first infusion is Day 1]	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Platelet Count Recovery	Defined by the number of days elapsed from Day 1 (the day of the first infusion of the IP) to the day when the platelet count is first known to be ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1	30 days
Duration of Response	Defined by the number of consecutive days for which the platelet count remains ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1.	30 days
Regression of Hemorrhage/Bleedings	Defined by the percentage of treated patients with hemorrhage/bleedings at Day 1 (i.e., the day of the first infusion, pre-infusion) who improve their diathesis during the clinical follow-up period ending on Day 15 ± 1.	15 days

Collaborators and Investigators

• Sponsor: Grifols Biologicals, LLC
• Collaborators: Instituto Grifols, S.A.
• Investigators: Principal Investigator: Ali Khojasteh, MD, Capitol Comprehensive Cancer Care Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: August 1, 2007
• First Submitted That Met QC Criteria: August 2, 2007
• First Posted (ESTIMATE): August 3, 2007

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: IVIG; ITP
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: IG0601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No