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
1 other identifier
interventional
64
4 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2008
Longer than P75 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2007
CompletedFirst Posted
Study publicly available on registry
August 3, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
May 5, 2017
CompletedJune 12, 2017
May 1, 2017
5.9 years
August 1, 2007
March 3, 2017
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Time to Platelet Count Recovery
30 days
Duration of Response
30 days
Regression of Hemorrhage/Bleedings
15 days
Study Arms (1)
IGIV3I Grifols 10% (All Subjects)
EXPERIMENTALAll subjects with Chronic ITP
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grifols Biologicals, LLClead
- Instituto Grifols, S.A.collaborator
Study Sites (45)
Phoenix Children's Hospital
Phoenix, Arizona, 85061, United States
Scottsdale Medical Specialists
Scottsdale, Arizona, 85258, United States
Arizona Oncology Associates
Tucson, Arizona, 85745, United States
Scripps Cancer Center
La Jolla, California, 92037, United States
Kenmar Research Institute, LLC
Los Angeles, California, 90057, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Cancer Center of Central Connecticut
Southington, Connecticut, 06489, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
VA Medical Center
Washington D.C., District of Columbia, 20422, United States
Halifax Health Medical Center
Daytona Beach, Florida, 32114, United States
Hematology Oncology Associates
Lake Worth, Florida, 33461, United States
Lakeland Regional Cancer Center
Tampa, Florida, 33607-6307, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33607-6307, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University School of Medicine Winship Cancer Center
Atlanta, Georgia, 30322, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
University of Iowa Children's Hospital
Iowa City, Iowa, 52242, United States
Children's Hospital
New Orleans, Louisiana, 70118, United States
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, 49048, United States
CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
Lansing, Michigan, 48910, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
Capital Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109, United States
UMDNJ-RWJ Medical School
New Brunswick, New Jersey, 08901, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Children's Hospital, University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Western Pennsylvannia Hospital
Pittsburgh, Pennsylvania, 15224, United States
Baptist Cancer Center
Beaumont, Texas, 77705, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Tyler Hematology Oncology PA
Tyler, Texas, 75701, United States
MCV Hospital
Richmond, Virginia, 23298, United States
University of Alberta
Edmonton, Alberta, T6G 2H7, Canada
St. Joseph's Healthcare
Hamilton, Ontario, L8N4A6, Canada
Narayana Hrudayalaya Hospitals
Karnataka, Bangalore, 560099, India
Shalby Hospitals
Ahmedabad, 380015, India
St. John's Medical College Hospital
Bangalore, 560034, India
Artemis Health Institute
Haryāna, 122001, India
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, 700 016, India
Christian Medical College
Ludhiana, 141008, India
Kodlikeri Hospital
Maharashtra, 431001, India
Grant Medical Foundation, Ruby Hall Clinic
Pune, 411001, India
Sahyadri Specialty Hospital
Pune, 411004, India
Apple Hospital
Surat, 395002, India
Christian Medical College
Vellore, 632004, India
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
Related Publications (1)
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.
PMID: 30499734DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Henry Li, PhD
- Organization
- Grifols Therapeutics Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Khojasteh, MD
Capitol Comprehensive Cancer Care Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2007
First Posted
August 3, 2007
Study Start
May 1, 2008
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
June 12, 2017
Results First Posted
May 5, 2017
Record last verified: 2017-05