Idiopathic Thrombocytopenic PurpuraPhase 3NCT00511147
IGIV Study for Chronic ITP Patients Ages 3-70
A Phase 3 study testing IGIV3I Grifols 10% in people with Idiopathic Thrombocytopenic Purpura, run by Grifols Biologicals, LLC at 45 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- IGIV3I Grifols 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 45 sitesin 4 countries
- Study dates
- May 2008to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
45 sites in 4 countries.
45 sites in 4 countries
United States31 sites
Emory University School of Medicine Winship Cancer Center
Atlanta, Georgia, 30322
Baptist Cancer Center
Beaumont, Texas, 77705
Halifax Health Medical Center
Daytona Beach, Florida, 32114
Cook Children's Medical Center
Fort Worth, Texas, 76104
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
University of Mississippi
Jackson, Mississippi, 39216
Capital Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, 49048
Scripps Cancer Center
La Jolla, California, 92037
Hematology Oncology Associates
Lake Worth, Florida, 33461
CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
Lansing, Michigan, 48910
Kenmar Research Institute, LLC
Los Angeles, California, 90057
UMDNJ-RWJ Medical School
New Brunswick, New Jersey, 08901
Children's Hospital
New Orleans, Louisiana, 70118
Mt. Sinai Medical Center
New York, New York, 10029
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital, University of Oklahoma
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
Phoenix Children's Hospital
Phoenix, Arizona, 85061
Western Pennsylvannia Hospital
Pittsburgh, Pennsylvania, 15224
MCV Hospital
Richmond, Virginia, 23298
Scottsdale Medical Specialists
Scottsdale, Arizona, 85258
Cancer Center of Central Connecticut
Southington, Connecticut, 06489
Lakeland Regional Cancer Center
Tampa, Florida, 33607-6307
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33607-6307
Arizona Oncology Associates
Tucson, Arizona, 85745
Tyler Hematology Oncology PA
Tyler, Texas, 75701
Georgetown University
Washington D.C., District of Columbia, 20007
VA Medical Center
Washington D.C., District of Columbia, 20422
Cleveland Clinic Florida
Weston, Florida, 33331
India11 sites
Shalby Hospitals
Ahmedabad, 380015
St. John's Medical College Hospital
Bangalore, 560034
Artemis Health Institute
Haryāna, 122001
Narayana Hrudayalaya Hospitals
Karnataka, Bangalore, 560099
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, 700 016
Christian Medical College
Ludhiana, 141008
Kodlikeri Hospital
Maharashtra, 431001
Grant Medical Foundation, Ruby Hall Clinic
Pune, 411001
Sahyadri Specialty Hospital
Pune, 411004
Apple Hospital
Surat, 395002
Christian Medical College
Vellore, 632004
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2H7
St. Joseph's Healthcare
Hamilton, Ontario, L8N4A6
About this study
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
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.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- IGIV3I Grifols 10%
- Keywords
- IVIG, ITP
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGIV3I Grifols 10%Biological
Also called Intravenous immunoglobulin
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.
| Study group | Role | What they receive |
|---|---|---|
| IGIV3I Grifols 10% (All Subjects) | Experimental | All subjects with Chronic ITP Receives: Biological: IGIV3I Grifols 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 8 days
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startMay 2008
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Biologicals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Responsible party
- Sponsor
- Investigators
- Ali Khojasteh, MD, Principal investigator, Capitol Comprehensive Cancer Care Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511147
- Sponsor's protocol ID
- IG0601
- Status last verified
- May 2017
- First submitted
- 1 Aug 2007
- Last updated
- 12 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 30499734
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00511147
- Acronym / sponsor ID
- IG0601
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- IVIG, ITP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Grifols Biologicals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Study start
- May 2008
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGIV3I Grifols 10% (All Subjects) | Experimental | Biological: IGIV3I Grifols 10%All subjects with Chronic ITP |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGIV3I Grifols 10%Also: Intravenous immunoglobulinIGIV3I 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. | Biological | IGIV3I Grifols 10% (All Subjects) |
Primary outcome
Response Rate
Time frame: 8 days
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]
3 secondary outcomes
Time to Platelet Count Recovery
Time frame: 30 days
Duration of Response
Time frame: 30 days
Regression of Hemorrhage/Bleedings
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30499734Apte 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.
Related trials for Idiopathic Thrombocytopenic Purpura
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
Not yet recruitingPhase 1
Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias
Immune Thrombocytopenia (ITP)
Not yet recruitingObservational study
Study of Thyroid Dysfunction in Immune Thrombocytopenic Purpura Patients
Thyroid Dysfunction, Immune Thrombocytopenic Purpura
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Khojasteh, MD principal investigator
Capitol Comprehensive Cancer Care Clinic
45 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IGIV3I Grifols 10% in people with Idiopathic Thrombocytopenic Purpura, run by Grifols Biologicals, LLC at 45 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, India, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.