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NCT00547365 · OUTCOME

Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)

Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction · Source last updated 2013-09-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants with positive response
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.

Analysis population: Two of ten patients with AL cardiac involvement who received IGIV infusions were analyzed (other eight individuals were removed from study before completion due to death/conditions unrelated to IGIV, loss to follow-up, or physician decision).

Groups in this outcome

Human Immune Globulin Intravenous (IGIV)

Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Human Immune Globulin Intravenous (IGIV)2

Reported measurements

Source class 1
Values in participants with positive response · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Human Immune Globulin Intravenous (IGIV)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.
groups
  1. description
    Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.
    id
    OG000
    title
    Human Immune Globulin Intravenous (IGIV)
param Type
NUMBER
population Description
Two of ten patients with AL cardiac involvement who received IGIV infusions were analyzed (other eight individuals were removed from study before completion due to death/conditions unrelated to IGIV, loss to follow-up, or physician decision).
reporting Status
POSTED
time Frame
Up to 1 year
title
Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)
type
PRIMARY
unit Of Measure
participants with positive response

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice