Purpura, Thrombocytopenic, IdiopathicPhase 2NCT00220727
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
A Phase 2 study testing Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified in people with Purpura, Thrombocytopenic, Idiopathic, run by Grifols Therapeutics LLC at 1 site in United States.
Trial summary
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Oct 2003
- Phase
- Phase 2
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent from patient or legal guardian (according to institutional review board requirements)obtained prior to initiation of any study related procedures
- Male and female subjects age between 12 and 75 years
- Confirmed diagnosis of ITP logged in medical records available prior to entry into the trial.
- Patients must have a platelet count < 30 x Giga/L (this level can be higher if clinically indicated).
- Previously splenectomized patients may be included.
- Any previously conducted bone marrow aspirations if conducted following diagnosis of ITP must be consistent with the ITP diagnosis (increased or normal levels of megakaryocytes in otherwise normal bone marrow).
Who cannot join
- History of allergic or other clinically significant reaction to human gamma globulin or other plasma proteins and/or blood products.
- Female patient who is pregnant or lactating or is not on an adequate program of contraception if of child-bearing potential.
- Documented history of selective immunoglobulin A (IgA) deficiency (serum <5.0 mg/dL) and known antibodies to IgA.
- Currently on intermittent prednisone therapy. Prednisone therapy is allowed only if the patient has been on stable daily doses of prednisone for the preceding month and maintains the same treatment regimen throughout the study.
- Renal or liver impairment defined by creatinine > 2.5 mg/dL, or direct bilirubin >1.5 X the upper limit of normal or liver transaminases (AST or ALT) > 3 times the upper limit of normal.
- Received anti-D or IGIV infusions within the past 14 days
Show all 14Show fewer
- Pre-treatment with the exception of acetominophen, routinely required to control/ameliorate IGIV infusion-related adverse events (AEs), or any patient who has been, unresponsive to IGIV therapy for their ITP
- History or clinical evidence of medical conditions felt to be the underlying cause of their thrombocytopenia. Such conditions commonly include systemic lupus erythematosus, history of chronic lymphocytic leukemia, dysplasia, agammaglobulinemia, treatment with heparin, quinidine, quinine, trimethoprim-sulfamethoxazole, or ticlopidine or any other drug thought to be the cause of patient's thrombocytopenia, congenital or hereditary thrombocytopenia, or pseudothrombocytopenia (clumping on peripheral blood smear)
- Conditions that could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- Congestive heart failure (New York Heart Association Stage III or IV)
- Diabetes mellitus
- Paraproteinemia
- Concomitant nephrotoxic drugs
- Hemoglobin level more than 2g/L below the lower limit of normal.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital
New York, New York, 10021-4885
About this study
Official title: Randomized, Controlled, Open Study Investigating IGIV-C, 10% Given at Different Infusion Rates on Intravascular Hemolysis in Patients With Idiopathic (Immune) Thrombocytopenic Purpura (ITP)
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates.
Read the detailed description
This is a prospective, randomized, single-center, open, cross-over trial in patients with a confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated thrombocytopenia in a patient with no other clinically apparent associated conditions or factors that are known to cause thrombocytopenia as defined by the ITP Practice Guidelines Committee of the American Society of Hematology.
Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) at a dose of 1.0 g/kg will be given on 2 occasions as a single daily infusion for platelet counts < 30,000 microliters (uL) or if clinically indicated, at maximum intervals of six weeks. Eligible patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C infusion at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min. Conversely patients randomized to Group 2 will receive their first IGIV-C infusion at a rate of 0.14 mL/kg/min and their second infusion at a rate of 0.08 mL/kg/min according to the following schema:
Group 1:
- Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min)
- Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
Group 2:
- Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min)
- Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Being tested
- Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
- Keywords
- Idiopathic (Immune) Thrombocytopenic Purpura, Immunoglobulin G
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Purpura, Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedDrug
Also called Gamunex®, IGIVnex®, Gaminex, IGIV-C
IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min) Receives: Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified |
| Group 2 | Experimental | Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min) Receives: Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free Hemoglobin
Free hemoglobin as a measure to assess hemolysis.
Measured: 24 hours after treatment
Hematocrit
Hematocrit as a measure to assess hemolysis
Measured: 24 hrs after treatment
Red Blood Cells
Red blood cells as a measure to assess hemolysis
Measured: 24 hrs after treatment
Change From Baseline in Platelet Levels
Measured: 24 hours Post infusion and Day 7
Secondary outcomes (1)
Number of Subjects With Infusion Related Adverse Events
Measured: 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionOct 2003
- Study completionOct 2003
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 Purpura, Thrombocytopenic, IdiopathicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Bussel, MD, Principal investigator, New York Presbyterian Hospital-Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220727
- Sponsor's protocol ID
- 100422
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 27 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bussel JB, Hanna K; IGIV-C in ITP Study Group. Safety and tolerability of a novel chromatography-based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura. Am J Hematol. 2007 Mar;82(3):192-8. doi: 10.1002/ajh.20822.
PubMed 17109385
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open Study Investigating IGIV-C, 10% Given at Different Infusion Rates on Intravascular Hemolysis in Patients With Idiopathic (Immune) Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT00220727
- Acronym / sponsor ID
- 100422
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Keywords
- Idiopathic (Immune) Thrombocytopenic Purpura, Immunoglobulin G
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates.
Detailed description
This is a prospective, randomized, single-center, open, cross-over trial in patients with a confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated thrombocytopenia in a patient with no other clinically apparent associated conditions or factors that are known to cause thrombocytopenia as defined by the ITP Practice Guidelines Committee of the American Society of Hematology.
Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) at a dose of 1.0 g/kg will be given on 2 occasions as a single daily infusion for platelet counts < 30,000 microliters (uL) or if clinically indicated, at maximum intervals of six weeks. Eligible patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C infusion at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min. Conversely patients randomized to Group 2 will receive their first IGIV-C infusion at a rate of 0.14 mL/kg/min and their second infusion at a rate of 0.08 mL/kg/min according to the following schema:
Group 1:
- Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min)
- Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
Group 2:
- Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min)
- Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedInfusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min) |
| Group 2 | Experimental | Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedInfusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min) |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent from patient or legal guardian (according to institutional review board requirements)obtained prior to initiation of any study related procedures
- Male and female subjects age between 12 and 75 years
- Confirmed diagnosis of ITP logged in medical records available prior to entry into the trial.
- Patients must have a platelet count < 30 x Giga/L (this level can be higher if clinically indicated).
- Previously splenectomized patients may be included.
Key exclusion criteria (14 listed)
- History of allergic or other clinically significant reaction to human gamma globulin or other plasma proteins and/or blood products.
- Female patient who is pregnant or lactating or is not on an adequate program of contraception if of child-bearing potential.
- Documented history of selective immunoglobulin A (IgA) deficiency (serum <5.0 mg/dL) and known antibodies to IgA.
- Currently on intermittent prednisone therapy. Prednisone therapy is allowed only if the patient has been on stable daily doses of prednisone for the preceding month and maintains the same treatment regimen throughout the study.
- Renal or liver impairment defined by creatinine > 2.5 mg/dL, or direct bilirubin >1.5 X the upper limit of normal or liver transaminases (AST or ALT) > 3 times the upper limit of normal.
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 |
|---|---|---|
| Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedAlso: Gamunex®, IGIVnex®, Gaminex, IGIV-CIGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min. | Drug | Group 1, Group 2 |
Primary outcome
Free Hemoglobin
Time frame: 24 hours after treatment
Free hemoglobin as a measure to assess hemolysis.
Hematocrit
Time frame: 24 hrs after treatment
Hematocrit as a measure to assess hemolysis
Red Blood Cells
Time frame: 24 hrs after treatment
Red blood cells as a measure to assess hemolysis
Change From Baseline in Platelet Levels
Time frame: 24 hours Post infusion and Day 7
1 secondary outcome
Number of Subjects With Infusion Related Adverse Events
Time frame: 48 hours after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17109385Bussel JB, Hanna K; IGIV-C in ITP Study Group. Safety and tolerability of a novel chromatography-based intravenous immunoglobulin when administered at a high infusion rate in patients with immune thrombocytopenic purpura. Am J Hematol. 2007 Mar;82(3):192-8. doi: 10.1002/ajh.20822.
- FDA-Approved Product Labeling - Gamunex®Link provided by the sponsor.
- FDA Product Approval - Gamunex®Link provided by the sponsor.
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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.
James Bussel, MD principal investigator
New York Presbyterian Hospital-Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified in people with Purpura, Thrombocytopenic, Idiopathic, run by Grifols Therapeutics LLC at 1 site in United States.
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 6 inclusion and 14 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 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Aug 2014). 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?
Free Hemoglobin (time frame: 24 hours after treatment). The study lists 4 primary outcomes in all. 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 NCT00220727, 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 27 Apr 2016.