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Intravenous Gammaglobulin for Sickle Cell Pain Crises

NCT01757418 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-31

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Immune Globulin Intravenous (IVIG)

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.

OTHER

Normal saline

A single dose of normal saline administered within 24 hours of hospital admission for uncomplicated pain crisis.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Case Western Reserve University

    collaborator OTHER

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Kerry Morrone, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2024-12-18
Completion
2024-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757418 on ClinicalTrials.gov