Immunologic Deficiency SyndromePhase 3NCT00220766
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
A Phase 3 study testing Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Dextrose, 5% in Water in people with Immunologic Deficiency Syndrome and Agammaglobulinemia, run by Grifols Therapeutics LLC at 13 sites in 2 countries.
Trial summary
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency
- What is being tested?
- Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Dextrose, 5% in Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Aug 2002to Mar 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial
- Signed an informed consent written informed consent prior to initiation of any study related procedures
- Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg
Who cannot join
- History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products
- Documented history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
- Isolated IgG subclass deficiency with a normal total serum IgG level
- Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction.
- Pretreatment with anti-pyretics or anti-histamines
- Congestive heart failure (New York Heart Association stage greater than Class II)
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- Renal insufficiency (creatinine >2.5 mg/dL)
- Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse events (AEs)
- Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain adequate trough levels
- Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States9 sites
Departments of Medicine and Microbiology
Birmingham, Alabama, 35294
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Optimed Research, LLC
Columbus, Ohio, 43235
National Jewish Medical and Researach Center
Denver, Colorado, 80206
The Clinical Trials Center, Children's Hospital
New Orleans, Louisiana, 70118
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408
Allergy, Asthma, and Immunology
Omaha, Nebraska, 68124
University of South Florida College of Medicine
St. Petersburg, Florida, 33701
International Center for Interdisciplinary Studies of Immunology
Washington D.C., District of Columbia, 20007
Canada4 sites
3031 Hospital Drive Northwest
Calgary, Alberta, T2N 2T8
Saint Michael's Hospital
Toronto, Ontario, M4V 1R2
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
St. Paul's Hospital
Vancouver, British Columbia, V6H 3K2
About this study
Official title: IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
Read the detailed description
This is a prospective, single blind, randomized, multi-center cross-over trial in patients with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune Deficiency will be treated with two daily infusions given 3-4 weeks apart at the fixed individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any subject with an established dose in the range of 200-399 mg/kg will be assigned to receive 400 mg/kg during the course of the study during the same dosing schedule established prior to entry into the study.
After a screening period lasting not more than four weeks, patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C, 10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min, whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema below.
Group 1:
- Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
- Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
Group 2:
- Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
- Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
- Conditions
- Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, Common Variable Immunodeficiency
- Being tested
- Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Dextrose, 5% in Water
- Keywords
- Primary Immune Deficiency, IGIV, Immunoglobulin G
- Medical subject headings
- Immunologic Deficiency Syndromes, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, Common Variable Immunodeficiency, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography PurifiedDrug
Also called Gamunex, IGIVnex, Gaminex, IGIV-C
Dextrose, 5% in WaterDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min) Receives: Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified; Drug: Dextrose, 5% in Water |
| Group 2 | Experimental | Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) Receives: Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified; Drug: Dextrose, 5% in Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infusion related adverse events
Measured: within 72 hours after infusion
Secondary outcomes (1)
All adverse events
Measured: within 72 hours after infusion
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 startAug 2002
- Primary completionAug 2002
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunologic Deficiency SyndromeStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erwin Gelfand, MD, Principal investigator, National Jewish Medical and Research Center, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220766
- Sponsor's protocol ID
- 100348
- Status last verified
- Sep 2009
- First submitted
- 13 Sep 2005
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients
- ClinicalTrials.gov ID
- NCT00220766
- Acronym / sponsor ID
- 100348
- Conditions
- Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, Common Variable Immunodeficiency
- Keywords
- Primary Immune Deficiency, IGIV, Immunoglobulin G
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
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/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
Detailed description
This is a prospective, single blind, randomized, multi-center cross-over trial in patients with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune Deficiency will be treated with two daily infusions given 3-4 weeks apart at the fixed individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any subject with an established dose in the range of 200-399 mg/kg will be assigned to receive 400 mg/kg during the course of the study during the same dosing schedule established prior to entry into the study.
After a screening period lasting not more than four weeks, patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C, 10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min, whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema below.
Group 1:
- Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
- Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
Group 2:
- Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
- Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Drug: Dextrose, 5% in WaterInfusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min) |
| Group 2 | Experimental | Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Drug: Dextrose, 5% in WaterInfusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial
- Signed an informed consent written informed consent prior to initiation of any study related procedures
- Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg
Key exclusion criteria (11 listed)
- History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products
- Documented history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
- Isolated IgG subclass deficiency with a normal total serum IgG level
- Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction.
- Pretreatment with anti-pyretics or anti-histamines
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 Intravenous [Human], 10% Caprylate/Chromatography PurifiedAlso: Gamunex, IGIVnex, Gaminex, IGIV-C | Drug | Group 1, Group 2 |
| Dextrose, 5% in Water | Drug | Group 1, Group 2 |
Primary outcome
Infusion related adverse events
Time frame: within 72 hours after infusion
1 secondary outcome
All adverse events
Time frame: within 72 hours after infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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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.
Erwin Gelfand, MD principal investigator
National Jewish Medical and Research Center, Denver, CO
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified and Dextrose, 5% in Water in people with Immunologic Deficiency Syndrome and Agammaglobulinemia, run by Grifols Therapeutics LLC at 13 sites in 2 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 3 inclusion and 11 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 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infusion related adverse events (time frame: within 72 hours after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2009.