Sickle Cell DiseasePhase 1/2NCT01757418
Intravenous Gammaglobulin for Sickle Cell Pain Crises
A Phase 1/2 study testing Immune Globulin Intravenous (IVIG) and Normal saline in people with Sickle Cell Disease and Pain, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is safe and effective in the acute treatment of pain crises in sickle cell disease. Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD) Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Sickle Cell Disease, Pain
- What is being tested?
- Immune Globulin Intravenous (IVIG) and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to 18 Dec 2024
- Phase
- Phase 1/2
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Documented Sickle Cell Disease (SS or S-β thalassemia genotype)
- Age 12-65 years for Phase 1 (Completed), 6-13.99 years for Phase 2 (Ongoing)
- Normal stroke risk as assessed by transcranial Doppler (TCD). A normal TCD in subjects 16 years of age and younger within the year prior to study drug administration are required
- Uncomplicated acute vaso-occlusive crisis requiring hospital admission and parenteral narcotic analgesics
- If prescribed Voxelotor: Consistent daily use of voxelotor in the past week AND able to continue Voxelotor inpatient OR no reported use in prior week
Who cannot join
- Concomitant acute process, including acute chest syndrome, potential serious infection, or clinically significant bleeding
- Fever > 38.5° C and clinical suspicion of infection
- Serum alanine aminotransferase >4x Upper Limit of Normal (ULN)
- Serum creatinine ≥1.3 mg/dL (or > than 95th percentile for age) or >300 mg/dL protein in spot urinalysis
- Known condition associated with renal dysfunction including but not limited to diabetes mellitus, uncontrolled hypertension, multiple myeloma, and congestive heart failure
- Any clinical evidence of prior stroke
Show all 22Show fewer
- Prior thromboses or current estrogen use
- Current estrogen use
- Hb < 5 g/dL or > 10 g/dL
- Known Immunoglobulin A (IgA) deficiency or known allergy to gamma globulin
- Pregnancy or breastfeeding
- Current participation in another investigational drug study
- Current enrollment in a hypertransfusion program
- Previous participation in current study less than 3 months ago
- Current treatment with chronic transfusion
- Vaccination with a live attenuated virus in the preceding 6 weeks
- Documented history of illicit (e.g., heroin, cocaine) drug abuse
- Subject is otherwise not an appropriate study candidate, in the investigator's judgement, such as concern for opioid addiction or comorbid psychiatric diagnoses that may contribute to secondary gain in prolonged use of opioids or hospital stay
- Greater than 24 hours from time of presentation to the hospital for VOC
- Atrial fibrillation
- Right to left cardiac shunting due to patent foramen ovale or other anatomic cause
- Known magnetic resonance imaging/angiography (MRI/A) evidence of stroke or clinically significant central nervous system (CNS) vasculopathy at any age (Imaging done if clinically indicated)
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is safe and effective in the acute treatment of pain crises in sickle cell disease.
Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD)
Read the detailed description
Patients will be randomized to a single dose of IVIG versus normal saline placebo during an uncomplicated pain crisis. Length of vaso-occlusive crisis (VOC) and other secondary endpoints will be monitored.
Phase I: To determine the tolerability and obtain preliminary data on the clinical efficacy of IVIG treatment in a randomized, double-blind, placebo-controlled, dose escalation Phase I clinical study of sickle cell disease patients, ages 12-65, admitted for acute vaso-occlusive crisis.
Phase II: To evaluate the effect of a single dose of 400mg/kg of intravenous (IV) Gamunex on length of VOC in subjects 6-13.99 years of age (initially 8-65 years of age, see "NOTES/CLARIFICATION below) hospitalized for sickle cell VOC in a randomized, double blind placebo-controlled Phase II trial. To further evaluate safety of a single dose of 400mg/kg of IV Gamunex in subjects 6-65 years of age hospitalized for sickle cell VOC.
NOTES/CLARIFICATION:
The following is a timeline of the 'evolution' of the required Age Range as per eligibility criteria for this study:
Initial Age Range: 8-65 years of age Effective 1/2/2013: 12-65 years of age Effective 3/31/2015: 8-21 years of age Effective 6/22/2018: 8-13 years of age Effective 7/11/2019: 6-13.99 years of age
- Conditions
- Sickle Cell Disease, Pain
- Being tested
- Immune Globulin Intravenous (IVIG), Normal saline
- Keywords
- Sickle Cell Disease, Pain, Immune Globulin
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous (IVIG)Drug
Also called GAMUNEX (Talecris Biotherapeutics)
A single dose of intravenous immune globulin administered within 24 hours of hospital presentation. The maximum dose in Phase I was 800 mg/kg. The dose for Phase II is 400mg/kg.
Normal salineOther
Also called Placebo
A single dose of normal saline administered within 24 hours of hospital admission for uncomplicated pain crisis.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Immune Globulin (IVIG) | Experimental | IVIG used in the trial is the GAMUNEX brand, at doses up through 800 mg/kg in Phase 1 and at 400mg/kg in Phase 2. Receives: Drug: Immune Globulin Intravenous (IVIG) |
| Normal saline | Placebo comparator | An equivalent volume (weight-based) of normal saline Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of vaso-occlusive crisis (VOC)
Length (duration) of vaso-occlusive crisis as measured from the time of presentation to the emergency room to end of VOC defined as 12 hours from the last dose of parenteral opioid analgesia for the treatment of VOC prior to hospital discharge. Group results will be summarized in number of days using univariate statistics.
Measured: Number of days from time of presentation to emergency room to end of crisis, average 4 days and maximum 30 days
Secondary outcomes (10)
Total Opioid Use
The total intravenous morphine equivalent use from the end of infusion to discharge will be compared between the IVIG and placebo group. This will require conversion of total amount of different opioids to the equivalent amounts of IV morphine in milligrams. Standard tables for equianalgesic opioid dosing will be used for these conversions. These tables account for opioid type, route of administration, and incomplete cross-tolerance, as needed, and are adjusted for body weight. Group results will be summarized in milligrams of opioid per kilogram of body weight (mg/kg) using univariate statistics.
Measured: From study drug infusion to end of crisis, average 4 days and maximum 30 days
Time to end of vaso-occlusive crisis
Time to end of vaso-occlusive crisis as measured from start of study drug infusion to end of VOC end of VOC defined as 12 hours from the last dose of parenteral opioid analgesia for the treatment of VOC prior to hospital discharge. Group results will be summarized in number of days using univariate statistics.
Measured: Number of days from start of study drug infusion to end of crisis, average 4 days and maximum 30 days
Length of Hospitalization
Length (duration) of Hospitalization will be summarized by study arm in months/days using univariate statistics.
Measured: From admission to discharge, average 4 days and maximum 30 days
Change in Macrophage-1 Antigen (Mac-1) expression
Change in Mac-1 expression levels from prior to infusion to 24 hours following infusion will be assessed by the appropriate in vitro adhesion assay to measure adhesion to cellular surfaces. Mac-1 is a cell surface receptor found on lymphocytes and leukocytes and serves as a marker for binding and adhesion. Mac-1 expression levels increase upon activation by inflammatory stimuli leading to a higher concentration of Mac-1 molecules on the cell's surface. Percentage change in Mac-1 from pre-infusion will be summarized by study arm using univariate statistics.
Measured: From Pre-infusion to 24-hours post-infusion
Change in Lactate Dehydrogenase (LDH) levels
Change in LDH levels from prior to infusion to 24 hours following infusion will be assessed. Percentage change in LDH concentration (in U/L) from pre-infusion will be summarized by study arm using univariate statistics. While normal LDH ranges vary by age/gender and thresholds have not been established for this study, higher LDH levels may serve as inflammatory biomarkers of hemolysis in patients with sickle cell disease and also be indicators of acute or chronic tissue damage.
Measured: From Pre-infusion to 24-hours post-infusion
Change in Hemoglobin (Hb) levels
Change in Hb levels from prior to infusion to 24 hours following infusion will be assessed. Percentage change in Hb concentration (in g/dL) from pre-infusion will be summarized by study arm using univariate statistics. While normal Hb ranges vary by age/gender and thresholds have not been established for this study, in patients with sickle cell disease, decreased Hb levels may be indicative of anemia, increased risk of thromboembolic events, and organ and tissue damage.
Measured: From Pre-infusion to 24-hours post-infusion
Change in High-sensitivity C-reactive protein (hsCRP) levels
Change in hsCRP levels from admission to 24 hours following infusion will be assessed. Percentage change in hsCRP concentration (in mg/L) from admission will be summarized by study arm using univariate statistics. hsCRP serves a biomarker for inflammation. While normal ranges for hsCRP vary by age/gender and thresholds have not been established for this study, higher hsCRP levels may serve as a laboratory correlate of hospitalizations for pain or vaso-occlusive events in patients with sickle cell disease.
Measured: From admission to 24-hours post-infusion, average 4 days
Rate of transfer to Intensive Care Unit (ICU)
The percentage of patients who are admitted to the hospital's ICU for an emergent condition will be summarized by study arm.
Measured: From admission to discharge, average 4 days and maximum 30 days
Diagnosis leading to transfer to the ICU
Diagnoses leading to transfer to the ICU will be summarized by study arm.
Measured: From admission to discharge, average 4 days and maximum 30 days
Number and type of Transfusions
The number and types of intervening packed red blood cell transfusions administered during the study will be summarized by study arm. Types of red blood cell transfusions will be categorized (e.g., acute, intermittent, chronic, simple, exchange) and will be administered as clinically indicated and ordered by the physician in accordance with NIH-NHLBI evidence-based management of sickle cell disease guidelines.
Measured: From study drug infusion to discharge, average 4 days and maximum 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startNov 2008
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), Case Western Reserve University, Grifols Therapeutics LLC
- Responsible party
- Sponsor
- Investigators
- Kerry Morrone, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757418
- Sponsor's protocol ID
- 09-06-172
- Other IDs
- FD-R-005341-01
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2012
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang J, Shi PA, Chiang EY, Frenette PS. Intravenous immunoglobulins reverse acute vaso-occlusive crises in sickle cell mice through rapid inhibition of neutrophil adhesion. Blood. 2008 Jan 15;111(2):915-23. doi: 10.1182/blood-2007-04-084061. Epub 2007 Oct 11.
PubMed 17932253Turhan A, Jenab P, Bruhns P, Ravetch JV, Coller BS, Frenette PS. Intravenous immune globulin prevents venular vaso-occlusion in sickle cell mice by inhibiting leukocyte adhesion and the interactions between sickle erythrocytes and adherent leukocytes. Blood. 2004 Mar 15;103(6):2397-400. doi: 10.1182/blood-2003-07-2209. Epub 2003 Nov 20.
PubMed 14630831Shi PA, Manwani D, Olowokure O, Nandi V. Serial assessment of laser Doppler flow during acute pain crises in sickle cell disease. Blood Cells Mol Dis. 2014 Dec;53(4):277-82. doi: 10.1016/j.bcmd.2014.04.001. Epub 2014 May 21.
PubMed 24857171Manwani D, Frenette PS. Vaso-occlusion in sickle cell disease: pathophysiology and novel targeted therapies. Blood. 2013 Dec 5;122(24):3892-8. doi: 10.1182/blood-2013-05-498311. Epub 2013 Sep 19.
PubMed 24052549Manwani D, Chen G, Carullo V, Serban S, Olowokure O, Jang J, Huggins M, Cohen HW, Billett H, Atweh GF, Frenette PS, Shi PA. Single-dose intravenous gammaglobulin can stabilize neutrophil Mac-1 activation in sickle cell pain crisis. Am J Hematol. 2015 May;90(5):381-5. doi: 10.1002/ajh.23956. Epub 2015 Apr 1.
PubMed 25616042Manwani D, Xu C, Lee SK, Amatuni G, Cohen HW, Carullo V, Morrone K, Davila J, Shi PA, Ireland K, Keenan J, Frenette PS. Randomized phase 2 trial of Intravenous Gamma Globulin (IVIG) for the treatment of acute vaso-occlusive crisis in patients with sickle cell disease: Lessons learned from the midpoint analysis. Complement Ther Med. 2020 Aug;52:102481. doi: 10.1016/j.ctim.2020.102481. Epub 2020 Jun 9.
PubMed 32951731Jang JE, Hidalgo A, Frenette PS. Intravenous immunoglobulins modulate neutrophil activation and vascular injury through FcgammaRIII and SHP-1. Circ Res. 2012 Apr 13;110(8):1057-66. doi: 10.1161/CIRCRESAHA.112.266411. Epub 2012 Mar 13.
PubMed 22415018
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain
- ClinicalTrials.gov ID
- NCT01757418
- Acronym / sponsor ID
- 09-06-172
- Conditions
- Sickle Cell Disease, Pain
- Keywords
- Sickle Cell Disease, Pain, Immune Globulin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), Case Western Reserve University, Grifols Therapeutics LLC
- Study start
- Nov 2008
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 31 Dec 2012 (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 purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is safe and effective in the acute treatment of pain crises in sickle cell disease.
Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD)
Detailed description
Patients will be randomized to a single dose of IVIG versus normal saline placebo during an uncomplicated pain crisis. Length of vaso-occlusive crisis (VOC) and other secondary endpoints will be monitored.
Phase I: To determine the tolerability and obtain preliminary data on the clinical efficacy of IVIG treatment in a randomized, double-blind, placebo-controlled, dose escalation Phase I clinical study of sickle cell disease patients, ages 12-65, admitted for acute vaso-occlusive crisis.
Phase II: To evaluate the effect of a single dose of 400mg/kg of intravenous (IV) Gamunex on length of VOC in subjects 6-13.99 years of age (initially 8-65 years of age, see "NOTES/CLARIFICATION below) hospitalized for sickle cell VOC in a randomized, double blind placebo-controlled Phase II trial. To further evaluate safety of a single dose of 400mg/kg of IV Gamunex in subjects 6-65 years of age hospitalized for sickle cell VOC.
NOTES/CLARIFICATION:
The following is a timeline of the 'evolution' of the required Age Range as per eligibility criteria for this study:
Initial Age Range: 8-65 years of age Effective 1/2/2013: 12-65 years of age Effective 3/31/2015: 8-21 years of age Effective 6/22/2018: 8-13 years of age Effective 7/11/2019: 6-13.99 years of age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Intravenous Immune Globulin (IVIG) | Experimental | Drug: Immune Globulin Intravenous (IVIG)IVIG used in the trial is the GAMUNEX brand, at doses up through 800 mg/kg in Phase 1 and at 400mg/kg in Phase 2. |
| Normal saline | Placebo comparator | Other: Normal salineAn equivalent volume (weight-based) of normal saline |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Documented Sickle Cell Disease (SS or S-β thalassemia genotype)
- Age 12-65 years for Phase 1 (Completed), 6-13.99 years for Phase 2 (Ongoing)
- Normal stroke risk as assessed by transcranial Doppler (TCD). A normal TCD in subjects 16 years of age and younger within the year prior to study drug administration are required
- Uncomplicated acute vaso-occlusive crisis requiring hospital admission and parenteral narcotic analgesics
- If prescribed Voxelotor: Consistent daily use of voxelotor in the past week AND able to continue Voxelotor inpatient OR no reported use in prior week
Key exclusion criteria (22 listed)
- Concomitant acute process, including acute chest syndrome, potential serious infection, or clinically significant bleeding
- Fever > 38.5° C and clinical suspicion of infection
- Serum alanine aminotransferase >4x Upper Limit of Normal (ULN)
- Serum creatinine ≥1.3 mg/dL (or > than 95th percentile for age) or >300 mg/dL protein in spot urinalysis
- Known condition associated with renal dysfunction including but not limited to diabetes mellitus, uncontrolled hypertension, multiple myeloma, and congestive heart failure
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 (IVIG)Also: GAMUNEX (Talecris Biotherapeutics)A single dose of intravenous immune globulin administered within 24 hours of hospital presentation. The maximum dose in Phase I was 800 mg/kg. The dose for Phase II is 400mg/kg. | Drug | Intravenous Immune Globulin (IVIG) |
| Normal salineAlso: PlaceboA single dose of normal saline administered within 24 hours of hospital admission for uncomplicated pain crisis. | Other | Normal saline |
Primary outcome
Length of vaso-occlusive crisis (VOC)
Time frame: Number of days from time of presentation to emergency room to end of crisis, average 4 days and maximum 30 days
Length (duration) of vaso-occlusive crisis as measured from the time of presentation to the emergency room to end of VOC defined as 12 hours from the last dose of parenteral opioid analgesia for the treatment of VOC prior to hospital discharge. Group results will be summarized in number of days using univariate statistics.
10 secondary outcomes
Total Opioid Use
Time frame: From study drug infusion to end of crisis, average 4 days and maximum 30 days
Time to end of vaso-occlusive crisis
Time frame: Number of days from start of study drug infusion to end of crisis, average 4 days and maximum 30 days
Length of Hospitalization
Time frame: From admission to discharge, average 4 days and maximum 30 days
Change in Macrophage-1 Antigen (Mac-1) expression
Time frame: From Pre-infusion to 24-hours post-infusion
Change in Lactate Dehydrogenase (LDH) levels
Time frame: From Pre-infusion to 24-hours post-infusion
Change in Hemoglobin (Hb) levels
Time frame: From Pre-infusion to 24-hours post-infusion
Change in High-sensitivity C-reactive protein (hsCRP) levels
Time frame: From admission to 24-hours post-infusion, average 4 days
Rate of transfer to Intensive Care Unit (ICU)
Time frame: From admission to discharge, average 4 days and maximum 30 days
Diagnosis leading to transfer to the ICU
Time frame: From admission to discharge, average 4 days and maximum 30 days
Number and type of Transfusions
Time frame: From study drug infusion to discharge, average 4 days and maximum 30 days
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 31 Mar 2026.
- Background: PubMed 17932253Chang J, Shi PA, Chiang EY, Frenette PS. Intravenous immunoglobulins reverse acute vaso-occlusive crises in sickle cell mice through rapid inhibition of neutrophil adhesion. Blood. 2008 Jan 15;111(2):915-23. doi: 10.1182/blood-2007-04-084061. Epub 2007 Oct 11.
- Background: PubMed 14630831Turhan A, Jenab P, Bruhns P, Ravetch JV, Coller BS, Frenette PS. Intravenous immune globulin prevents venular vaso-occlusion in sickle cell mice by inhibiting leukocyte adhesion and the interactions between sickle erythrocytes and adherent leukocytes. Blood. 2004 Mar 15;103(6):2397-400. doi: 10.1182/blood-2003-07-2209. Epub 2003 Nov 20.
- Background: PubMed 24857171Shi PA, Manwani D, Olowokure O, Nandi V. Serial assessment of laser Doppler flow during acute pain crises in sickle cell disease. Blood Cells Mol Dis. 2014 Dec;53(4):277-82. doi: 10.1016/j.bcmd.2014.04.001. Epub 2014 May 21.
- Background: PubMed 24052549Manwani D, Frenette PS. Vaso-occlusion in sickle cell disease: pathophysiology and novel targeted therapies. Blood. 2013 Dec 5;122(24):3892-8. doi: 10.1182/blood-2013-05-498311. Epub 2013 Sep 19.
- Background: PubMed 25616042Manwani D, Chen G, Carullo V, Serban S, Olowokure O, Jang J, Huggins M, Cohen HW, Billett H, Atweh GF, Frenette PS, Shi PA. Single-dose intravenous gammaglobulin can stabilize neutrophil Mac-1 activation in sickle cell pain crisis. Am J Hematol. 2015 May;90(5):381-5. doi: 10.1002/ajh.23956. Epub 2015 Apr 1.
- Background: PubMed 32951731Manwani D, Xu C, Lee SK, Amatuni G, Cohen HW, Carullo V, Morrone K, Davila J, Shi PA, Ireland K, Keenan J, Frenette PS. Randomized phase 2 trial of Intravenous Gamma Globulin (IVIG) for the treatment of acute vaso-occlusive crisis in patients with sickle cell disease: Lessons learned from the midpoint analysis. Complement Ther Med. 2020 Aug;52:102481. doi: 10.1016/j.ctim.2020.102481. Epub 2020 Jun 9.
- Background: PubMed 22415018Jang JE, Hidalgo A, Frenette PS. Intravenous immunoglobulins modulate neutrophil activation and vascular injury through FcgammaRIII and SHP-1. Circ Res. 2012 Apr 13;110(8):1057-66. doi: 10.1161/CIRCRESAHA.112.266411. Epub 2012 Mar 13.
- Individual participant dataSharing planned: No
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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.
Kerry Morrone, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immune Globulin Intravenous (IVIG) and Normal saline in people with Sickle Cell Disease and Pain, run by Albert Einstein College of Medicine 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 5 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 31 Mar 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Length of vaso-occlusive crisis (VOC) (time frame: Number of days from time of presentation to emergency room to end of crisis, average 4 days and maximum 30 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 NCT01757418, which also lists 7 linked publications.
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 31 Mar 2026.