Can a common immune treatment ease sickle cell pain?
NCT ID NCT01757418
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a medicine called Intravenous Immunoglobulin (IVIG) is safe and helps shorten painful episodes in people with sickle cell disease. 300 participants aged 6 to 65 took part. The goal was to see if IVIG could reduce how long the pain lasts and how much strong pain medicine is needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
300 people
The number who actually took part.
- Start date
-
Nov 2008
- Finished
-
Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 13 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Each subject must fulfill each of the following Inclusion/Exclusion criteria at screening and continue to fulfill these criteria prior to dosing: Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Montefiore Medical Center
The Bronx, New York, 10467, United States
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