CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
IVIG +1 moredrug
Likely dose
10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeksAI-extracted
Key inclusion· 3
  • ✓Lung transplant recipient at least 3 months after transplant surgery
  • ✓Serum immunoglobulin G (IgG) level below 500 mg/dL
  • ✓Stable medical regimen (presumed: stable immunosuppressive therapy)
Key exclusion· 5
  • ✕Acute rejection present
  • ✕Active infection
  • ✕Contraindication to IVIG therapy
  • ✕Pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00115778
NCT00115778Phase 2Completed
CompareCT.gov

IVIG for Acquired Immunodeficiency in Lung Transplant Patients

Columbia University·interventional·Posted Jun 27, 2005·Updated Mar 5, 2019

In Brief

A Phase 2 clinical trial evaluating IVIG and Placebo for Hypogammaglobulinemia and Lung Transplantation. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogammaglobulinemia, Lung Transplantation
CountriesUnited States
CollaboratorsGrifols Therapeutics LLC

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2005
Enrollment StartJun 1, 2005
Primary CompletionAug 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 21.0 years ago

Interventions

IVIGdrug

10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks

Placeboother

0.1% Albumin in an equal volume to the investigational product