COMPLETED

Intravenous Gammaglobulin for Sickle Cell Pain Crises

Conditions

Sickle Cell Disease Pain Immune Globulin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine whether intravenous immune globulin 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)

Official Title

Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain

Quick Facts

Study Start:2008-11

Study Completion:2024-12-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT01757418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Principal Investigator

Kerry Morrone, MD

PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Study Locations (Sites)

Montefiore Medical Center

The Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

Kerry Morrone, MD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2008-11

Study Completion Date2024-12-18

Study Record Updates

Study Start Date2008-11

Study Completion Date2024-12-18

Terms related to this study

Keywords Provided by Researchers

Sickle Cell Disease
Pain
Immune Globulin

Additional Relevant MeSH Terms

Sickle Cell Disease
Pain