Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT01757418
Brief Summary:
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)
Detailed Description:
Patients will be randomized to a single dose of IVIG versus normal saline placebo during an uncomplicated pain crisis. Length of VOC and other secondary endpoints will be monitored.
Phase 1: 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 admitted for acute vaso-occlusive crisis.
Phase II: To evaluate the effect of a single dose of 400mg/kg of IV Gamunex on length of VOC in subjects 8-14 years of age hospitalized for sickle cell VOC in a randomized, double blind placebo-controlled Phase 2 trial. To further evaluate safety of a single dose of 400mg/kg of IV Gamunex in subjects 8-14 years of age hospitalized for sickle cell VOC
Study:
NCT01757418
Study Brief:
Protocol Section:
NCT01757418