Intravenous Gammaglobulin for Sickle Cell Pain Crises
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)
|Sickle Cell Disease Pain||Drug: Immune Globulin Intravenous Drug: Normal saline||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain|
- 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 30days ]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
- Total opioid use in equivalent of mg of IV morphine [ Time Frame: From study drug infusion to end of crisis, average 4 days and maximum 30days ]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
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||July 2020|
|Estimated Primary Completion Date:||September 2019 (Final data collection date for primary outcome measure)|
Experimental: Immune Globulin Intravenous
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.
Drug: Immune Globulin Intravenous
A single dose of intravenous immune globulin or saline placebo 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.
Other Name: GAMUNEX (Talecris Biotherapeutics)
Placebo Comparator: Normal saline
An equivalent volume (weight-based)of normal saline
Drug: Normal saline
A single dose of normal saline administered within 24 hours of hospital admission for uncomplicated pain crisis.
Other Name: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757418
|Contact: Deepa G Manwani, M.Dfirstname.lastname@example.org|
|Contact: Karen Irelandemail@example.com|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Deepa G Manwani, MD 718-741-2342 firstname.lastname@example.org|
|Principal Investigator: Deepa G Manwani, MD|
|Principal Investigator:||Deepa G Manwani, M.D||Albert Einstein College of Medicine, Inc.|