IGIV Study for Chronic ITP Patients Ages 3-70
Primary Purpose
Idiopathic Thrombocytopenic Purpura
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IGIV3I Grifols 10%
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring IVIG, 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
Sites / Locations
- Phoenix Children's Hospital
- Scottsdale Medical Specialists
- Arizona Oncology Associates
- Scripps Cancer Center
- Kenmar Research Institute, LLC
- Children's Hospital of Orange County
- Connecticut Children's Medical Center
- Cancer Center of Central Connecticut
- Georgetown University
- VA Medical Center
- Halifax Health Medical Center
- Hematology Oncology Associates
- Lakeland Regional Cancer Center
- St. Joseph's Children's Hospital of Tampa
- Cleveland Clinic Florida
- Emory University School of Medicine Winship Cancer Center
- Advocate Hope Children's Hospital
- University of Iowa Children's Hospital
- Children's Hospital
- Kalamazoo Hematology & Oncology
- CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
- University of Mississippi
- Capital Comprehensive Cancer Care Clinic
- UMDNJ-RWJ Medical School
- Mt. Sinai Medical Center
- Children's Hospital, University of Oklahoma
- Western Pennsylvannia Hospital
- Baptist Cancer Center
- Cook Children's Medical Center
- Tyler Hematology Oncology PA
- MCV Hospital
- University of Alberta
- St. Joseph's Healthcare
- Narayana Hrudayalaya Hospitals
- Shalby Hospitals
- St. John's Medical College Hospital
- Artemis Health Institute
- Netaji Subhash Chandra Bose Cancer Research Institute
- Christian Medical College
- Kodlikeri Hospital
- Grant Medical Foundation, Ruby Hall Clinic
- Sahyadri Specialty Hospital
- Apple Hospital
- Christian Medical College
- Fundacion de Investigacion de Diego
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IGIV3I Grifols 10% (All Subjects)
Arm Description
All subjects with Chronic ITP
Outcomes
Primary Outcome Measures
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]
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT00511147
First Posted
August 1, 2007
Last Updated
May 8, 2017
Sponsor
Grifols Biologicals, LLC
Collaborators
Instituto Grifols, S.A.
1. Study Identification
Unique Protocol Identification Number
NCT00511147
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grifols Biologicals, LLC
Collaborators
Instituto Grifols, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura
Keywords
IVIG, ITP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IGIV3I Grifols 10% (All Subjects)
Arm Type
Experimental
Arm Description
All subjects with Chronic ITP
Intervention Type
Biological
Intervention Name(s)
IGIV3I Grifols 10%
Other Intervention Name(s)
Intravenous immunoglobulin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response Rate
Description
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]
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Time to Platelet Count Recovery
Description
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
Time Frame
30 days
Title
Duration of Response
Description
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.
Time Frame
30 days
Title
Regression of Hemorrhage/Bleedings
Description
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.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Khojasteh, MD
Organizational Affiliation
Capitol Comprehensive Cancer Care Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85061
Country
United States
Facility Name
Scottsdale Medical Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Kenmar Research Institute, LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Georgetown University
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
VA Medical Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Halifax Health Medical Center
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Hematology Oncology Associates
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607-6307
Country
United States
Facility Name
St. Joseph's Children's Hospital of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607-6307
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory University School of Medicine Winship Cancer Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Advocate Hope Children's Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
University of Iowa Children's Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Children's Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Kalamazoo Hematology & Oncology
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Capital Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
UMDNJ-RWJ Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Children's Hospital, University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Western Pennsylvannia Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Baptist Cancer Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77705
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Tyler Hematology Oncology PA
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
MCV Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2H7
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Name
Narayana Hrudayalaya Hospitals
City
Karnataka
State/Province
Bangalore
ZIP/Postal Code
560099
Country
India
Facility Name
Shalby Hospitals
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Facility Name
St. John's Medical College Hospital
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
Artemis Health Institute
City
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Netaji Subhash Chandra Bose Cancer Research Institute
City
Kolkata
ZIP/Postal Code
700 016
Country
India
Facility Name
Christian Medical College
City
Ludhiana
ZIP/Postal Code
141008
Country
India
Facility Name
Kodlikeri Hospital
City
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Grant Medical Foundation, Ruby Hall Clinic
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Sahyadri Specialty Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Apple Hospital
City
Surat
ZIP/Postal Code
395002
Country
India
Facility Name
Christian Medical College
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
30499734
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.
Results Reference
derived
Learn more about this trial
IGIV Study for Chronic ITP Patients Ages 3-70
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