Intravenous Gammaglobulin for Sickle Cell Pain Crises

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Sickle Cell DiseasePain
Interventions
DRUG

Immune Globulin Intravenous (IVIG)

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

Normal saline

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

Trial Locations (1)

10467

RECRUITING

Montefiore Medical Center, The Bronx

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Food and Drug Administration (FDA)

FED

collaborator

Case Western Reserve University

OTHER

collaborator

Grifols Therapeutics LLC

INDUSTRY

lead

Deepa Manwani

OTHER